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PRESS RELEASES
Carestream’s Cone Beam CT System Designed to Offer Orthopaedic Practices Affordable, High-Quality 3D Extremity Images
Mumbai, India, March 2016 — Carestream showcased its CARESTREAM OnSight 3D Extremity System that uses cone beam CT (CBCT) technology to capture weight-bearing and other types of extremity exams at the American Academy of Orthopaedic Surgeons (AAOS) annual meeting and exhibit held from 2nd March 2016 to 4th March 2016. This affordable system is intended to offer high-quality, low-dose 3D imaging for orthopaedic practices and other healthcare providers. The CBCT system (INVESTIGATIONAL: Not available for commercial sale) is being designed to include advanced image reconstruction and artifact correction technology.
“Our CBCT system is designed to allow orthopedic practices to capture high-quality 3D extremity images and conduct a patient consultation in a single visit,” said Helen Titus, Carestream’s Worldwide Marketing Director for X-ray & Ultrasound solutions. “This is highly productive for orthopedic specialists while simultaneously delivering greater patient convenience. Pre-surgical and post-surgical exams can also be performed by this system.”
She adds that orthopedics is a major area of focus for Carestream because of the prevalence of musculoskeletal conditions among people of all ages.
The company is currently conducting trials and research studies of the CBCT system in the United States and Europe. UBMD Orthopedics & Sports Medicine (Buffalo, N.Y.), Erie County Medical Center (Buffalo, N.Y.) and Carestream are conducting an institutional IRB-approved clinical study designed to help orthopedic surgeons more accurately and objectively diagnose the degree of instability of the patella (knee cap).
“We compare images obtained on a conventional CT scanner to those obtained on the prototype CBCT scanner while the patient is standing, the quadriceps is active and the knee is flexed to 30 degrees,” said Dr. John Marzo, a physician with UBMD Orthopedics & Sports Medicine, Associate Professor of Clinical Orthopedics, Jacobs School of Medicine & Biomedical Sciences, University at Buffalo and former Medical Director, Buffalo Bills.
“The orthopedic specialists involved in the clinical study are extremely satisfied with the image quality from the CBCT scanner and have provided positive feedback on the benefits delivered by the use of this technology for weight-bearing exams,” he adds.
Radiologists, technologists and other team members at Erie County Medical Center (ECMC) have provided valuable feedback on the system’s design and performance during research studies and trials conducted at their facility. Medical staff from Great Lakes Medical Imaging—a leading radiology group and official imaging service of the Buffalo Bills and the Buffalo Sabres—also have provided support to these patient studies.
ECMC includes an advanced academic medical center with 602 inpatient beds, on- and off-campus health centers, more than 30 outpatient specialty care services and a 390-bed long-term care facility. It is a major teaching facility for the University at Buffalo.
HUS Medical Imaging Center, based in Helsinki, Finland, is the site of the first European clinical study of Carestream’s 3D extremity system in pre- and post-operative cases. During the six-month project, experienced radiologists will evaluate the system’s image quality in bone structure, fractures and the level of metal artifacts. In addition, a medical physicist will assess the physical image and radiation exposure.
These clinical studies and other research projects will help guide Carestream’s development of new CBCT systems that use less radiation than traditional CT; are compact, affordable and portable; and could be used in a wide range of facilities.
“This CBCT scanner has the potential to become a non-invasive tool to evaluate a host of orthopedic conditions that affect the biomechanical behavior of the joints, such as arthritis, meniscus loss, instability and malalignment syndromes,” Titus reports.
courtesy: press release criss cross communications
Mumbai, India, March 2016 — Carestream showcased its CARESTREAM OnSight 3D Extremity System that uses cone beam CT (CBCT) technology to capture weight-bearing and other types of extremity exams at the American Academy of Orthopaedic Surgeons (AAOS) annual meeting and exhibit held from 2nd March 2016 to 4th March 2016. This affordable system is intended to offer high-quality, low-dose 3D imaging for orthopaedic practices and other healthcare providers. The CBCT system (INVESTIGATIONAL: Not available for commercial sale) is being designed to include advanced image reconstruction and artifact correction technology.
“Our CBCT system is designed to allow orthopedic practices to capture high-quality 3D extremity images and conduct a patient consultation in a single visit,” said Helen Titus, Carestream’s Worldwide Marketing Director for X-ray & Ultrasound solutions. “This is highly productive for orthopedic specialists while simultaneously delivering greater patient convenience. Pre-surgical and post-surgical exams can also be performed by this system.”
She adds that orthopedics is a major area of focus for Carestream because of the prevalence of musculoskeletal conditions among people of all ages.
The company is currently conducting trials and research studies of the CBCT system in the United States and Europe. UBMD Orthopedics & Sports Medicine (Buffalo, N.Y.), Erie County Medical Center (Buffalo, N.Y.) and Carestream are conducting an institutional IRB-approved clinical study designed to help orthopedic surgeons more accurately and objectively diagnose the degree of instability of the patella (knee cap).
“We compare images obtained on a conventional CT scanner to those obtained on the prototype CBCT scanner while the patient is standing, the quadriceps is active and the knee is flexed to 30 degrees,” said Dr. John Marzo, a physician with UBMD Orthopedics & Sports Medicine, Associate Professor of Clinical Orthopedics, Jacobs School of Medicine & Biomedical Sciences, University at Buffalo and former Medical Director, Buffalo Bills.
“The orthopedic specialists involved in the clinical study are extremely satisfied with the image quality from the CBCT scanner and have provided positive feedback on the benefits delivered by the use of this technology for weight-bearing exams,” he adds.
Radiologists, technologists and other team members at Erie County Medical Center (ECMC) have provided valuable feedback on the system’s design and performance during research studies and trials conducted at their facility. Medical staff from Great Lakes Medical Imaging—a leading radiology group and official imaging service of the Buffalo Bills and the Buffalo Sabres—also have provided support to these patient studies.
ECMC includes an advanced academic medical center with 602 inpatient beds, on- and off-campus health centers, more than 30 outpatient specialty care services and a 390-bed long-term care facility. It is a major teaching facility for the University at Buffalo.
HUS Medical Imaging Center, based in Helsinki, Finland, is the site of the first European clinical study of Carestream’s 3D extremity system in pre- and post-operative cases. During the six-month project, experienced radiologists will evaluate the system’s image quality in bone structure, fractures and the level of metal artifacts. In addition, a medical physicist will assess the physical image and radiation exposure.
These clinical studies and other research projects will help guide Carestream’s development of new CBCT systems that use less radiation than traditional CT; are compact, affordable and portable; and could be used in a wide range of facilities.
“This CBCT scanner has the potential to become a non-invasive tool to evaluate a host of orthopedic conditions that affect the biomechanical behavior of the joints, such as arthritis, meniscus loss, instability and malalignment syndromes,” Titus reports.
courtesy: press release criss cross communications
Perfint Healthcare Secures USFDA Clearance for MAXIO
Chennai, Tamil Nadu, India and Redmond, United States
Perfint Healthcare, a world leader in planning and targeting solutions for image guided interventional procedures in Oncology and Paincare, today announced that the company received the 510(K) clearance from the USFDA for commercial marketing of its MAXIO in the United States.
Commenting on the FDA 510(K) clearance, Mr. Nandakumar S, Chief Executive Officer, Perfint Healthcare said, “This is a significant milestone in the history of the company. We would like to dedicate this important achievement to the millions fighting Cancer and Pain. Our products, MAXIO and ROBIO, were used to perform over 2000 patient procedures around the world in the last year. This has been possible due to our focus on patient centricity and clinical excellence.”
He added, “The support from the Department of Biotechnology Government of India was timely and helped us reduce cost of R&D. I would like to congratulate my team and thank our clinical advisors for their significant contribution in this milestone achievement.”
Mr. Guruswamy K, Director-Sales, Perfint Healthcare further added, “We have been working with some of the best physicians in the USA over the last several years during the development and validation phases of MAXIO. Studies have been performed at the National Institutes of Health, Bethesda and Memorial Sloan Kettering Cancer Center, New York City. Obtaining the 510(K) clearance allows us to start commercial marketing of MAXIO in the USA. It also makes it easier to scale up in several other markets globally. We are hoping to achieve Rs 100 Crore in revenue this year.”
Commenting on this important achievement, Mr. Mohan Kumar, Director on board of Perfint and Partner, Norwest Venture Partners said “In 2012, about 2.5 Million patients were diagnosed with Liver and Lung Cancer. That number is only growing. Many of them are also inoperable. MAXIO has been proven to be very useful in providing tumor ablation therapy for such patients. Perfint with its established user base in Europe and Asia, now with the USFDA clearance, is uniquely positioned in the minimally invasive cancer care space”. Perfint is an outstanding example of Bio-Medical engineering that combines Robotics, Imaging software and Medical sciences, They are a terrific team.”
Commenting on other recent achievements and plans Mr. Nandakumar S added “We were recently awarded 3 patents by the US Patent office for our technologies. We also obtained the China FDA clearance recently. We hope to ramp in the USA and China in the coming quarters. We are raising additional equity capital to fund our next product roadmap and growth in global markets. Some of that funds will also be used for international acquisitions. We hope to achieve Rs 500 Cr in revenue in the next few years.”
Perfint’s flagship product, MAXIO is an image-guided, physician-controlled stereotactic CT accessory which helps physician see, plan, treat and verify during CT guided procedures like Tumor Ablation or Paincare.
Perfint has successfully raised $32.7MM through 4 rounds of venture funding with prominent investors such as IDG Ventures, Accel India Ventures, and Norwest Venture Partners participating. The company has a strong presence in India, APAC, Middle East, Europe & Australia among others and now eying lucrative markets like China and USA to further expand its global presence.
Courtesy: Press Release BWI
Perfint Healthcare, a world leader in planning and targeting solutions for image guided interventional procedures in Oncology and Paincare, today announced that the company received the 510(K) clearance from the USFDA for commercial marketing of its MAXIO in the United States.
Commenting on the FDA 510(K) clearance, Mr. Nandakumar S, Chief Executive Officer, Perfint Healthcare said, “This is a significant milestone in the history of the company. We would like to dedicate this important achievement to the millions fighting Cancer and Pain. Our products, MAXIO and ROBIO, were used to perform over 2000 patient procedures around the world in the last year. This has been possible due to our focus on patient centricity and clinical excellence.”
He added, “The support from the Department of Biotechnology Government of India was timely and helped us reduce cost of R&D. I would like to congratulate my team and thank our clinical advisors for their significant contribution in this milestone achievement.”
Mr. Guruswamy K, Director-Sales, Perfint Healthcare further added, “We have been working with some of the best physicians in the USA over the last several years during the development and validation phases of MAXIO. Studies have been performed at the National Institutes of Health, Bethesda and Memorial Sloan Kettering Cancer Center, New York City. Obtaining the 510(K) clearance allows us to start commercial marketing of MAXIO in the USA. It also makes it easier to scale up in several other markets globally. We are hoping to achieve Rs 100 Crore in revenue this year.”
Commenting on this important achievement, Mr. Mohan Kumar, Director on board of Perfint and Partner, Norwest Venture Partners said “In 2012, about 2.5 Million patients were diagnosed with Liver and Lung Cancer. That number is only growing. Many of them are also inoperable. MAXIO has been proven to be very useful in providing tumor ablation therapy for such patients. Perfint with its established user base in Europe and Asia, now with the USFDA clearance, is uniquely positioned in the minimally invasive cancer care space”. Perfint is an outstanding example of Bio-Medical engineering that combines Robotics, Imaging software and Medical sciences, They are a terrific team.”
Commenting on other recent achievements and plans Mr. Nandakumar S added “We were recently awarded 3 patents by the US Patent office for our technologies. We also obtained the China FDA clearance recently. We hope to ramp in the USA and China in the coming quarters. We are raising additional equity capital to fund our next product roadmap and growth in global markets. Some of that funds will also be used for international acquisitions. We hope to achieve Rs 500 Cr in revenue in the next few years.”
Perfint’s flagship product, MAXIO is an image-guided, physician-controlled stereotactic CT accessory which helps physician see, plan, treat and verify during CT guided procedures like Tumor Ablation or Paincare.
Perfint has successfully raised $32.7MM through 4 rounds of venture funding with prominent investors such as IDG Ventures, Accel India Ventures, and Norwest Venture Partners participating. The company has a strong presence in India, APAC, Middle East, Europe & Australia among others and now eying lucrative markets like China and USA to further expand its global presence.
Courtesy: Press Release BWI
Carestream’s Newest Image Acquisition/Mini-PACS Software Receives FDA 510(k) Clearance for Viewing on iPad Mobile Devices
New Tablet Viewer Option Can Help Enhance Patient Care at Urgent Care Facilities, Imaging Centers and Physicians’ Offices
Mumbai, India, May, 2014 — Carestream’s newest version of Image Suite Software has received FDA 510(k) Clearance for a Tablet Viewer option that allows viewing of X-ray imaging studies on the iPad 2. This capability is now available in many countries around the world. Users of Carestream’s latest version of Image Suite Software can add the Tablet Viewer Option, while users of previous generations of Image Suite software can upgrade to the newest software to gain access to the Tablet Viewer and other advanced features.
Image Suite delivers a flexible image acquisition, processing and storage platform that supports Carestream’s wireless DRX-1 systems as well as CR imaging systems and an optional mini-PACS. Image Suite offers Web-based patient scheduling, image review and reporting and flexible archiving solutions. This versatile offering is ideal for urgent care facilities, imaging centers and physicians’ offices.
“With the Tablet Viewer, consultations can be more personal since patients will be able to see evidence of their disease or condition on X-ray images as a physician is explaining diagnosis and treatment options,” said Heidi McIntosh, Carestream’s Global Marketing Manager for X-ray Solutions.
Physicians can also view patient images from home or any remote location on their iPad 2 mobile devices by logging into their mini-PACS system.
Image Suite Delivers Advanced Reading and Reporting Tools
Carestream’s optional mini-PACS also delivers advanced reading and reporting tools and supports a wide variety of specialty measurement tools including Lippman-Cobb angle, goniometry and coxometry. The software also supports transfer of images to OrthoView™ software for pre-operative orthopaedic planning and templating.
Image Suite systems provide DICOM storage for MR, CT and ultrasound exams and allows users to create, edit and view reports. Users can output imaging exams to CD/DVDs, DICOM printers and other PACS systems.
Courtesy: Press Release
Mumbai, India, May, 2014 — Carestream’s newest version of Image Suite Software has received FDA 510(k) Clearance for a Tablet Viewer option that allows viewing of X-ray imaging studies on the iPad 2. This capability is now available in many countries around the world. Users of Carestream’s latest version of Image Suite Software can add the Tablet Viewer Option, while users of previous generations of Image Suite software can upgrade to the newest software to gain access to the Tablet Viewer and other advanced features.
Image Suite delivers a flexible image acquisition, processing and storage platform that supports Carestream’s wireless DRX-1 systems as well as CR imaging systems and an optional mini-PACS. Image Suite offers Web-based patient scheduling, image review and reporting and flexible archiving solutions. This versatile offering is ideal for urgent care facilities, imaging centers and physicians’ offices.
“With the Tablet Viewer, consultations can be more personal since patients will be able to see evidence of their disease or condition on X-ray images as a physician is explaining diagnosis and treatment options,” said Heidi McIntosh, Carestream’s Global Marketing Manager for X-ray Solutions.
Physicians can also view patient images from home or any remote location on their iPad 2 mobile devices by logging into their mini-PACS system.
Image Suite Delivers Advanced Reading and Reporting Tools
Carestream’s optional mini-PACS also delivers advanced reading and reporting tools and supports a wide variety of specialty measurement tools including Lippman-Cobb angle, goniometry and coxometry. The software also supports transfer of images to OrthoView™ software for pre-operative orthopaedic planning and templating.
Image Suite systems provide DICOM storage for MR, CT and ultrasound exams and allows users to create, edit and view reports. Users can output imaging exams to CD/DVDs, DICOM printers and other PACS systems.
Courtesy: Press Release
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Unfors RaySafe Launches RaySafe S1: Dose Management Software Increases Patient Safety at Hospitals
______________________________________________________ Mumbai, Maharashtra, India, Monday, August 05, 2013 -- (Business Wire India) -- Unfors RaySafe (formerly Unfors Instruments), the leading independent supplier of radiation measurement solutions for the X-ray room, has extended its product portfolio to include the RaySafe S1, the first cloud-based dose management software of its kind. RaySafe S1 visualizes patient dose and provides role-based guidelines to help medical staff optimize dose and image quality. This enables hospitals to work according to the radiation safety principles of ALARA (As Low As Reasonably Achievable) and protects patients from unnecessary radiation while cutting costs for the hospitals by reducing waste scans. The software records patient doses during X-ray procedures but is also able to access historic data from past exams. Hospitals can use this information to develop and implement Dose Reference Levels. While many hospitals today may not be able to immediately identify a patient who was overexposed, RaySafe S1can automatically notify medical staff if patient doses deviate from the predefined levels.
"The medical application of X-rays has constantly increased in the past years and with it concerns about their health impact. With our products, we want to help people avoid unnecessary radiation and keep the necessary exposure as low as possible," explains CEO Magnus Kristoferson about the company's move towards the new software's development. Unfors RaySafe is the only company worldwide as of now to offer comprehensive solutions for the X-ray room - from quality assurance of X-ray equipment, to real-time dose monitoring for medical staff and dose management solutions for the benefit of the patient. The new RaySafe S1 software is now available for hospitals and clinics across the Asia Pacific. The cloud-based system is already successfully used to justify, optimize and control patient dose in Europe and the US and can smoothly be integrated in radiology departments with X-ray equipment from manufacturers that support the DICOM standard. Award-winning design and usability In addition to measurement accuracy, RaySafe products are also well known for their intuitive usability and innovative design. The Swedish company's dedication to simple, attractive forms supporting both functionality and operation has just been acknowledged by the jury of this year's internationally coveted Red Dot design award. The RaySafe S1 software has been awarded in the "Interface Design" category of the Red Dot Award: Communication Design 2013. This year, the panel of jurors reviewed 6,800 products entered for the Red Dot competition by companies and designers from 43 countries. Launched in 1955 to honor outstanding achievements in design, the Red Dot design award is today one of the largest and most renowned design competitions in the world. Unfors Instruments has changed its name to Unfors RaySafe Courtesy : Press Release BWI BGS Global Hospitals Organises the First Global Interventional Radiology Symposium
__________________________________________________________ Bangalore, Karnataka, India, Monday, August 05, 2013 -- (Business Wire India) -- -- Showcased a wide range of Interventional Radiology procedures performed at Global Hospitals
-- Knowledge sharing to help interventional Radiologists with better treatment plans and patient outcomes BGS Global Hospitals organised Global Interventional Radiology Symposium (GIRS 2013), the first in the country. The one day symposium was well attended by over 120 delegates from all over the country. The symposium showcased a wide range of Interventional Radiology procedures routinely performed at Global Hospitals in Bangalore, Chennai and Hyderabad. Dr M C Uthappa, Director of Interventional Radiology & Interventional Oncology, Global Hospitals, said, "Today, Interventional Radiology is an integral part of various clinical procedures, finding a role in vascular diseases, liver diseases, oncology, stroke management, women's health, paediatrics, and back pain. Interventional Radiology procedures are nonsurgical procedures and bring with them immense patient benefits, hence a preferred option for treatment in varicose veins, fibroids, prostate gland enlargement, etc." He added, " Available to us in India are a variety of new IR techniques that have been successfully incorporated into clinical practice, which involve the use of catheters, guide wires, balloons for angioplasty, coils, liquid embolizing agents, stents and stent grafts, radiofrequency ablation devices, thrombectomy devices, which is a boon to interventional radiologists." Patient benefits by treatment with Interventional Radiology -- Outpatient procedure (some require a short stay) -- General Anaesthesia is usually not required -- Risk, pain and recovery time reduced significantly -- Less expensive than surgery in majority of the cases The highlights of this symposium, which was inaugurated by Dr K. Ravindranath, Chairman & Managing Director of Global Hospitals Group were: 1.Interactive discussions followed the talks in the four main sessions 2.A special panel discussion was organised on Liver Cancer 3.Guest lecture by Dr SS Baijal, Director of Interventional Radiology, Medanta Hospital, New Delhi Source : Press Release BWI Healthcare Providers Rate CARESTREAM DRX-Evolution X-ray System Highest for Overall Performance
_______________________________________________________ Users of Company’s Digital Radiography System Give It
Top Ratings According to Latest KLAS Report Mumbai, India, June, 2013 — Carestream has again earned a top rating against major competitors for its digital X-ray systems that are based on its proven wireless DRX technology. As reported by KLAS in its just published “Digital X-Ray Performance 2013 – Impact of a Wireless Workflow,” the company’s CARESTREAM DRX-Evolution scored highest for overall performance. In a survey of more than 200 radiology professionals, the report stated that “Carestream has built on their wireless detector success with the DRX-Evolution. Providers are taking advantage of moving detectors between different rooms or mobile X-ray systems. The DRX-Evolution wireless rooms are also meeting provider needs with an intuitive user interface, great image quality and reliability.” Carestream also received the highest rating in three survey indicators which were "Implementation On Time,” “Usability” and "Quality of Training.” KLAS is independently owned and operated, and has ratings on more than 250 healthcare technology vendors and over 900 products and services. Headquartered in Orem, Utah, with researchers throughout North America, KLAS publishes approximately 60 performance and perception reports each year. In a section of the report titled “Bottom Line on Vendors,” Carestream’s DRX-Evolution system is described as follows: · “Reliable unit with great patient throughput. Easy-to-use and intuitive GUI consistent across CR and DR offerings. Detector battery life is meeting needs. Switching detectors works well, with nearly 40 percent using it.” In another part of the report titled “Special Questions Commentary”, users provided additional candid comments about the performance of Carestream’s DRX-Evolution: · “I would compare the DRX-Evolution to Apple's products. It is very intuitive and it tells users in layman's terms how to get procedures done. When it is trying to solve a problem, it tells us step by step how to get any type of procedure done.” · “This is an extremely efficient and user-friendly product.” The DRX-Evolution system can perform many different general radiology, trauma and emergency room X-ray procedures. Its ability to deliver rapid, high-quality images enables facilities to improve productivity and can help reduce radiology equipment expenses. The DRX-Evolution is designed to move around the patient instead of positioning the patient based on the configuration of the X-ray equipment, which can help enhance care. The system’s wireless DRX-1 detector can be removed from the wall stand or table to easily handle difficult imaging studies, as well as exams for patients in wheelchairs or on stretchers. Digital images are sent over a secure wireless network and appear on the system console in seconds. Carestream’s DRX detector forms the foundation for a highly productive family of innovative digital X-ray systems. Earlier this year, the company’s CARESTREAM DRX-Revolution Mobile X-ray System earned the top rating in MD Buyline’s First Quarter 2013 User Satisfaction Report. MD Buyline provides more than 3,000 hospitals with unbiased data on vendors, products, services and user satisfaction ratings. Courtesy : Press Release e-Radiograph offers a platform for radiologists to share best practices in medical imaging
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The Oslo Breast Cancer Screening Trial Concludes that the Use of 3D Mammography in Combination with a 2D Breast Exam Finds Significantly More Cancers than a 2D Breast Exam Alone
_______________________________________________________ First large-scale, peer-reviewed prospective clinical study shows that adding 3D mammography to a 2D breast screening exam enables doctors to detect 40% more invasive cancers while also reducing false positives
BEDFORD, Mass., Jan. 9, 2013 /PRNewswire/ -- Hologic, Inc. (Hologic or the Company) (NASDAQ: HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced that a groundbreaking new study published in Radiology, the Radiological Society of North America scientific journal, found that the addition of three dimensional (3D) mammography (breast tomosynthesis) screening technology to a 2D breast screening exam significantly increased cancer detection while reducing the number of false positives. The study, "Comparison of Digital Mammography Alone and Digital Mammography plus Tomosynthesis in a Population-based Screening Program," was led by Per Skaane, M.D., Ph.D. of Oslo University Hospital Ullevaal. The study was based on 12,631 screening examinations in a large hospital in Norway. The researchers using Hologic's 3D mammography technology in combination with a 2D mammogram found a significant increase in cancer detection rates, particularly for invasive cancers, and a simultaneous decrease in false-positive rates compared with 2D mammography alone. Significant findings include:
As a result of the large increase in the detection of invasive cancers rather than in situ cancers the authors of the paper state, "Perhaps our most important observation is that with the mammography-plus-tomosynthesis arm, the actual benefit, in terms of possibly improving outcome owing to earlier detection, may be larger than merely the difference in the total count or number of detected cancers." Rob Cascella, Hologic's President and Chief Executive Officer said, "A number of major papers demonstrating the value of 3D mammography have been published in the last few months. The Oslo trial is the first large-scale prospective study to show the additional cancers found with 3D mammography in combination with 2D mammography were invasive cancers—the very type of cancers we want to detect and treat early. 3D mammography is the best breast screening technology to date in that it finds significantly more invasive cancers while also reducing false positives. Most other imaging technologies for screening require users to compromise specificity (recall rate) for sensitivity (cancer detection). We believe the value of 3D mammography in breast cancer screening is most compelling." 3D mammography was approved for clinical use for breast cancer screening and diagnosis in the U.S. in February, 2011 and has been available in countries recognizing the CE mark since 2008. Hologic's 3D mammography technology is in use in 47 states and 30 countries outside the U.S. Unlike a screening 2D digital mammogram, which involves a single X-ray image of the breast, 3D mammography captures multiple, low-dose images from multiple angles around the breast. The images are then used to produce a 3D reconstruction of the breast. Dr. Per Skaane and his research team in Oslo are well known for their research. Their Oslo I and Oslo II trials were important studies comparing 2D digital mammography to screen-film for the detection of breast cancer. The study was published online in advance of print on the Radiology website. Hologic will post a Question and Answer document today within the investor relations section of Hologic's website at www.hologic.com/investors-overview. Forward Looking Statement Disclaimer This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic digital mammography systems. There can be no assurance the systems will achieve the benefits described herein and that such benefits will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of the systems can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein to reflect any change in the Company's expectations or any change in events, conditions or circumstances on which any such data or statements are based. Courtesy : http://investors.hologic.com/2013-01-09-The-Oslo-Breast-Cancer-Screening-Trial-Concludes-that-the-Use-of-3D-Mammography-in-Combination-with-a-2D-Breast-Exam-Finds-Significantly-More-Cancers-than-a-2D-Breast-Exam-Alone Northwestern radiology advances IVC filter removal
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20 FEB 2013 Inferior vena cava (IVC) filters do a great job of reducing the risk of pulmonary embolisms by stopping blood clots, usually originating in the lower extremities, from reaching the lungs. Some patients receive permanent filters and others are implanted with retrievable ones. While both types of filters can be removed, it can be a task that is sometimes easier said than done. “The longer the filter has been in place, the tougher it is to retrieve,” explains Robert Lewandowski, MD, who co-directs Northwestern Radiology’s IVC Filter Clinic with fellow interventional radiologist (IR) Robert Ryu, MD. Because of the body’s natural reaction to the presence of the IVC filter, scar tissue can form around the IVC filter struts and make it difficult, if not impossible, to remove the implanted medical device. Since launching the IVC Filter Clinic in January 2009, Northwestern’s Interventional Radiology Section has pioneered a novel approach to this vexing challenge. The department’s skilled IR experts employ the Excimer Laser Sheath, manufactured by Spectranetics Inc., to ablate scar tissue to approximately 50 microns. Emitting ultraviolet energy at the 308 nm wavelength, the low-temperature Excimer Laser Sheath safely and effectively removes scar tissue formation around deeply embedded filters. Northwestern is one of only two centers in the country using this state-of-the-art technology, with the majority of filter removals a complete success. “I recently removed a Greenfield filter that had been placed 12 years ago,” says Dr. Ryu, professor of radiology. IVC filters can cause symptoms many years after implantation. In this case, “the patient complained of a stabbing sensation in his abdomen, which prevented him from exercising. His CT scan showed that one of the filter struts had perforated his IVC and was impinging on his lumbar spine.” During an hour-long outpatient procedure, Dr. Ryu and his team removed the filter with the Excimer Laser Sheath. The patient went home later that day, with complete resolution of his abdominal pain. “We are seeing more referrals from the community for management of these challenging filters,” says Dr. Ryu. “We’re committed to providing expert consultation and clinical services for doctors whose patients have complex clinical problems.” The IVC Filter Clinic at Northwestern focuses on the comprehensive management of IVC filter-related medical issues and offers consultation, placement, retrieval, and follow-up care. The clinic has experienced significant growth in the past four years that has paralleled the increased use of IVC filters nationwide. “IVC filter usage is expected to increase by 5-10 percent annually for at least the next few years,” says Dr. Lewandowski, associate professor of radiology at the Feinberg School of Medicine at Northwestern University. “This growth really stresses the importance of our clinic and experienced management of patients and their IVC filters.” Consultations can be arranged through Karen Marshall, IVC Filter Clinical Coordinator at 312 695 1791, or by e-mail at kmarshall@nmff.org courtesy : http://www.radiology.northwestern.edu/news_items/northwestern-radiology-advances-ivc-filter-removal Enterprise imaging solutions to enable the comprehensive EMR featured at HIMSS 2013........................................................................................
Agfa HealthCare’s ICIS uniquely provides access, in clinically-relevant context, to multi-specialty patient imaging across the care continuum
> Provider organizations can maximize the value their EMR investment can return with experienced clinical and IT consultancy services. > Agfa HealthCare delivers accessibility to patient care information, including images, to multiple stakeholders driving Meaningful Use compliance, clinical collaboration, and patient empowerment. Leading the adoption of enterprise imaging information management solutions, Agfa HealthCare provides access, through the EMR, to create comprehensive, image-enabled medical records. This provides a longitudinal view of the patient's imaging throughout the enterprise, so that clinicians have greater insight for the clinical benefit of the patient. During HIMSS, Agfa HealthCare will demonstrate the significant clinical advances and IT efficiencies enabled by ICIS, Agfa HealthCare's Imaging Clinical Information System. ICIS is the enterprise imaging choice of many leading hospital networks. "In the delivery of care today, health systems around the world find themselves struggling to bring together data from various departments around the enterprise. Electronic health records are attempting to solve this problem for data that resides in a patient chart, but that solution leaves images behind," saidJames Jay, Vice President - Imaging Informatics, Agfa HealthCare. "As the use of images grows, so does the challenge of enabling access to images to all care providers. In addition, as more departments generate imaging data, simply consolidating storage does not solve the problem. Clinical workflow is needed to acquire, distribute and review these images. Agfa HealthCare is a leader in recognizing this challenge. ICIS, leveraging our XERO viewer, delivers a comprehensive framework to enable flexible workflows to bring images into every step of the care continuum. This gives clinicians a single point of access for all imaging data, integrated into the electronic health record, which can help reduce duplicate procedures and enable a highly efficient care process." Innovative consultant services Agfa HealthCare provides a consultancy approach to assist organizations as they formulate and execute their enterprise imaging strategic plan. The company recognizes that, while many conditions are shared throughout the healthcare industry, each system presents a unique combination of imaging-generating departments, resources, and EMR experience. Providing a secure single patient view Beyond image enabling the EMR, Agfa HealthCare, together with Orion Health, a global leader in health information exchange (HIE) and healthcare integration solutions, have image-enabled HIEs, further advancing collaboration and supporting ACOs. Images from Agfa HealthCare's ICIS platform can be integrated into a shared "single best view" of the patient via the Orion Health Clinical Portal*. By having a holistic view, hospitals and healthcare systems can begin treatment of the patient sooner and help reduce costs resulting from unnecessary repeat exams and duplicate test orders. The Orion Health Patient Portal* will also enable patients, their families and care teams to securely access a unified view of their electronic record including the entire longitudinal patient record and medical images thanks to the Agfa HealthCare technology platform. "Healthcare reform demands that clinical imaging become a strategic resource advancing continuity of care throughout the enterprise. Working with Orion Health, we help organizations meet Meaningful Use criteria by providing clinicians with a single point-of-care access to the patient's comprehensive medical record,"said Michael Green, President and CEO - Americas Region, Agfa HealthCare. "Our proven solutions meet today's healthcare enterprise interoperability challenges. Designed to create workflow and care efficiencies, we bring secure access of information to multi-specialty departments, referring physician networks, and the personal care support teams involved in a patient's care." * Work in progress Atomic Energy Regulatory Board (AERB) Signs Memorandum of Understanding (MoU) with the Governments of Maharashtra and Odisha for Setting up Directorate of Radiation Safety (DRS)
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The Atomic Energy Regulatory Board (AERB) has entered into an agreement with two State authorities of Maharashtra and Odisha for formation of State level Directorate of Radiation Safety for strengthening the regulator control on medical diagnostic X-ray facilities. The Memorandum of Understanding (MoU) to this effect was signed last month, first with the Aditional Chief Secretary, Public Health Department, Government of Maharashtra on January 18, 2013 and the second one with Principle Secretary, Health and Family Welfare Department to set up Directorate of Radiation Safety (DRS) in the respective States. With these, AERB has signed MoUs with a total of 10 States (Kerala, Mizoram, Madhya Pradesh, Tamil Nadu, Punjab, Chhattisgarh, Himachal Pradesh, Gujarat, Maharashtra and Odisha) of which DRS in Kerala and Mizoram are already functioning. Government of Uttar Pradesh, Bihar and Andhra Pradesh are in the process of signing MoUs shortly. It may be noted that diagnostic radiology facilities utilizing X-ray units are widely available in the country (approx. 50000) and a large number of persons undergo diagnostic X-ray procedures every year. These X-ray units if not designed or operated properly may lead to unwanted radiation exposure to the patients as well as the operators. The safety review and assessment of these machines is carried out by AERB of India which is the national regulatory body for enforcement of radiological safety regulations in the country. AERB has stipulated various regulatory requirements for such X-ray facilities such as Design Certification, Type Approval / No Objection Certificate, Approval of Layout, Registration of X-ray Equipment, Commissioning of X-ray Installations, Certification of Radiological Safety Officers (RSOs) and Certification of Service Engineers. In view of the tremendous increase in the medical diagnostic installations using medical X-ray units in the country, AERB has taken proactive steps to exercise regulatory control over all such installations by decentralizing the regulation of these units by having and MoU with State Government and Union Territories to set up Directorate of Radiation Safety in various States/Union Territories. The Atomic Energy Regulatory Board (AERB) was constituted on November 15, 1983 by the President of India by exercising the powers conferred by Section 27 of the Atomic Energy Act, 1962 (33 of 1962) to carry out certain regulatory and Safety functions under the Act. The regulatory authority of AERB is derived from the rules and notifications promulgated under the Atomic Energy Act, 1962 and the Environmental (Protection) Act, 1986. The headquarter is in Mumbai. Source : http://www.pib.nic.in/newsite/erelease.aspx?relid=92001 Medical societies to launch large-scale study on vein filter use Society of Interventional Radiology and Society for Vascular Surgery form new foundation, collaborate on multicenter trial to improve patient care.........................................................................................
Feb. 1, 2013 Joint press release from Society of Interventional Radiology and Society for Vascular Surgery FAIRFAX, Va.—The Society of Interventional Radiology and Society for Vascular Surgery jointly will launch PRESERVE—the first large-scale, multispecialty prospective study to evaluate the use of inferior vena cava (IVC) filters and related follow-up treatment. The study—along with the formation of the IVC Filter Study Group Foundation—are direct actions taken to address the August 2010 FDA medical alert detailing the possibility that retrievable IVC filters could move or break, potentially causing significant health risks for patients. SIR and SVS are in the process of determining a framework for the PRESERVE (PREdicting the Safety and Effectiveness of InferioR VEna Cava Filters) study, with the goal of obtaining a functional view of all filters placed in the United States. “PRESERVE data will allow a systematic, functional view, representative of all filters placed in the United States, thus, all stakeholders—individuals, health care professionals, insurers and government regulators—will be armed with the knowledge they need on patient risk and, subsequently, quality improvement in filter placement, management and retrieval,” said SIR President Marshall E. Hicks, M.D., FSIR. “This is a paradigm-shifting initiative: interventional radiologists and vascular surgeonscollaborating to launch a large-scale prospective study evaluating inferior vena cava filters reveals a lot about each specialty’s focus—and that focus is on patients, first and foremost,” noted SVS President Peter Gloviczki, M.D. The five-year study will evaluate the overall safety and efficacy of filters placed by doctors and intends to enroll 1,800 patients at approximately 50 centers in the United States. Members of the IVC Filter Study Group Foundation collectively discussed ways to respond to the FDA’s stated concerns. SIR and SVS are in the process of making a final decision for a contract research organization, completing protocol development and submitting the study for investigational device exemption (IDE) study with HIPAA (Health Insurance Portability and Accountability Act) compliance. Study directors are Matthew S. Johnson, M.D., FSIR, Indiana University School of Medicine, Indianapolis, Ind., and David L. Gillespie M.D., FACS, University of Rochester School of Medicine and Dentistry, Rochester, N.Y. Most filter manufacturers have agreed to participate in the study. According to the U.S. Surgeon General, between 350,000 and 600,000 people each year in the United States are affected by blood clots and between 100,000 and 180,000 people die of pulmonary embolism (a blood clot that travels to the lungs) each year. IVC filters are placed inside patients by vascular specialists to prevent blood clots from breaking free and traveling to the lungs or heart and causing a pulmonary embolism. FDA recommendations are that physicians remove the filters, which are designed to be retrievable, once the threat of pulmonary embolism has passed. The FDA warning said that all physicians were encouraged to consider the benefits and health risks of IVC filter removal for each patient. Members of the IVC Filter Study Group Foundation board of directors are SVS President Peter Gloviczki, M.D., Mayo Clinic College of Medicine, Rochester, Minn. (president); SIR President Marshall E. Hicks, M.D., FSIR, University of Texas MD Anderson Cancer Center, Houston (vice president); SVS Executive Director Rebecca M. Maron, CAE (secretary); SIR Executive Director Susan E. Sedory Holzer, MA, CAE (treasurer); John A. Kaufman, M.D., MS, FSIR, Dotter Interventional Institute, Portland, Ore. (SIR representative); and Peter Lawrence, M.D., UCLA Medical Center, Santa Monica (SVS representative). Learn more about the Society of Interventional Radiology at www.SIRweb.org and the Society for Vascular Surgery at www.vascularweb.org. source : Press Release : http://www.sirweb.org/news/newsPDF/Release_PRESERVE_Final_.pdf Inclusion of Virtual Colonoscopy as HEDIS® Screening Modality Could Increase Colorectal Cancer Screening Compliance, Study Suggests - January 10, 2013.........................................................................................
Availability of CT colonography (CTC), commonly known as virtual colonoscopy, is increasing colorectal cancer (CRC) screening rates across military medical facilities. Inclusion of CTC as a Healthcare Effectiveness Data and Information Set® (HEDIS®)-compliant colorectal cancer (CRC) screening test can potentially raise overall screening rates, according to a study in the January issue of the Journal of the American College of Radiology. The National Committee for Quality Assurance developed HEDIS to provide quality measures for the evaluation of standards of medical care across health plans. Although CTC is included in the most recent screening guidelines jointly released by the American Cancer Society, the ACR, and the U.S. Multi-Society Task Force on Colorectal Cancer in 2008, it has not been included as a qualifying test for the numerator of the HEDIS CRC screening metric. Current HEDIS measures for CRC screening include fecal occult blood testing, flexible sigmoidoscopy and colonoscopy. “The aim of our analysis was to quantify the use of CTC for CRC screening and demonstrate the potential impact of including CTC as a HEDIS-acceptable screening modality,” said Brooks D. Cash, MD, author of the study. Demographic and health care utilization data from the Military Health System Population Health Portal for January 1, 2005, through December 31, 2010, for individuals aged 50 to 75, were analyzed to determine the degree of overall utilization of CTC. Screening compliance for CRC per HEDIS was also estimated, and the incremental impact of adding HEDIS-eligible patients who had undergone CTC as their only CRC screening test was then evaluated for two similarly sized, regional Navy medical centers. Across all sites (10 Army, 4 Navy, 3 Air Force), 17,187 CTC studies were performed, with increasing utilization during the 6-year study period. At the two Navy medical centers, screening compliance ranged from 33.8 percent to 67.9 percent without CTC and 33.8 percent to 84 percent with CTC. “Our analysis demonstrates that CTC is being implemented with increasing frequency across military treatment facilities and that the inclusion of CTC in the currently defined NCQA numerator for CRC screening tests could improve HEDIS compliance metrics in the presence of an integrated CTC screening program,” said Cash. “Given the low rates of current HEDIS measures for CRC, it is important to expand this metric to include high-quality tests such as CTC that have the potential to significantly increase compliance with CRC screening guidelines and can be expected, over time, to contribute to further lowering of CRC-associated morbidity and mortality,” said Cash. Source : Press Release : http://www.acr.org/About-Us/Media-Center/Press-Releases/2013-Press-Releases/20130110Inclusion-of-Virtual-Colonoscopy-as-HEDIS-Screening-Modality ..............................................................................................................
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