GE Healthcare Submits the Final Module of Its Premarket Approval Application (PMA) for GE Breast Tomosynthesis OptionJuly 30, 2013 9:00 am | by Business Wire | News | Comments
GE Healthcare, a unit of General Electric Company (NYSE:GE), announced that it recently submitted to the U.S. Food and Drug Administration (FDA) the final module of its premarket approval application (PMA1) for GE Breast Tomosynthesis, an option of the Senographe Essential system.
Reason for Recall: GE Healthcare became aware of an incident at a VA Medical Center facility in the US. A patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. On July 03, 2013 GE notified hospitals...
Study in British Journal of Urology International Features a Practical Solution for MRI-Ultrasound Fusion to Enable Tumor-Targeted, Tissue-Preserving Prostate HIFU TreatmentJuly 25, 2013 2:16 pm | by The Associated Press | News | Comments
Study results published in the current issue of British Journal of Urology International (10.1111/bju.12223) demonstrate that new software to register and fuse information from magnetic resonance imaging (MRI) and ultrasound (US) images enables intraoperative visualization of tumors, not ordinarily seen in a US image.
Healthcare trade groups are pushing back against the Centers for Medicare & Medicaid Services, asking the federal healthcare agency to reconsider policies that would relax maintenance protocols for certain hospital-based medical devices.
Gamma Medica said it's closed a $16 million Series A round from Psilos Group Managers. The Northridge, Calif.-based company said it plans to use the cash to expand the commercial footprint of its LumaGen molecular breast imaging device and the LumaGuide biopsy model.
Infraredx, Inc., a medical device company committed to advancing the diagnosis and management of coronary artery disease, today announced the publication of key data supporting the ability of its TVC Imaging System to detect lipid core plaque in patients with ST-Segment Elevation Myocardial Infarction (STEMI).
China's Mindray Medical International Ltd. has closed on its $101.7 million acquisition of ultrasound technology company Zonare Medical Systems Inc. The deal, which was announced last month, was originally said to be for $105 million. The new purchase price accounts for working capital adjustments.
Hansen Medical and Philips Reinforce Collaboration in Robotic Systems for Endovascular InterventionsJuly 17, 2013 8:00 am | by The Associated Press | News | Comments
Hansen Medical and Royal Philips announced that they have reached an important milestone in their long-term collaboration by securing certified compatibility -- article 12 of the Medical Device Directive 93/42/EEC, as amended by 2007/47/EC -- between Hansen Medical's Magellan Robotic System and Philips' Allura interventional X-ray systems.
Froedtert & The Medical College of Wisconsin Clinical Cancer Center Joins Elekta and Philips Research Consortium on MRI-Guided Radiation TherapyJuly 16, 2013 9:00 am | by PR Newswire | News | Comments
Elekta (NSE: EKTAb) and Royal Philips (NYSE: PHG, AEX: PHIA) announced today that the Froedtert & The Medical College of Wisconsin Clinical Cancer Center (Milwaukee, Wisconsin) will join a consortium that is investigating the development of a magnetic resonance imaging (MRI) guided radiation therapy system.
Commercial Release of 3D (Breast Tomosynthesis) Biopsy Option Strengthens Hologic's Position as Provider of the Nation's Most Comprehensive Portfolio of Interventional Breast Health SolutionsJuly 15, 2013 4:15 pm | by PR Newswire | News | Comments
Hologic, Inc., a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products, with an emphasis on serving the healthcare needs of women, recently expanded its extensive array of interventional and imaging solutions for breast health with the launch of the world's first 3D breast biopsy option.
The medical device industry is constantly changing. New technologies and products enter the market, replacing outdated or inefficient equipment. There are numerous benefits in using LEDs for medical illumination applications including longer life, less heat, dynamic control, lower energy consumption, and in many cases, lower cost.
Given Imaging Ltd, a world leader in gastrointestinal medical devices and pioneer of capsule endoscopy, has announced that PillCam® COLON has been cleared by Japan's Pharmaceuticals & Medical Devices Agency for diagnosis of colonic disease when colonoscopy is required but difficult to conduct, including patients unwilling or unable to undergo colonoscopy.
Cardiologist Shashi Agarwal was sentenced to 2.5 years in jail for his role in a healthcare kickbacks scheme. The judge found Agarwal guilty of raking in more than $101,750 through an illegal deal with an Orange, N.J., MRI diagnostic facility to refer patients in exchange for cash.
Royal Philips and Georgia Regents Medical Center have announced a 15-year alliance to enable increasingly patient-centered approaches to care and to create an innovative business model that addresses current and future clinical, operational and equipment needs of GRMC’s multiple sites.
Lantos Technologies lit up $5.1 million of a hoped-for $18.8 million funding round for its 3D ear canal-mapping device, according to a regulatory filing. The Wakefield, Mass.-based company reported that 18 un-named investors joined the equity and options round.
On this episode of The Pulse, a device that helps train the brain to turn sounds into images, detecting cancer by imaging the consumption of sugar, biomedical applications for a new hydrogel, and a nanofiber mesh that treats tumors with both thermotherapy and chemotherapy.
GE Healthcare issued an urgent field safety notice on its nuclear medicine systems after part of an Infinia Hawkeye 4 system collapsed and killed a patient in a New York Veterans Administration hospital. Last month, a 66-year-old patient was crushed by the Infinia system, a gamma camera, while undergoing a procedure.
Putting medical devices on the network provides a large number of benefits, such as supporting telemedicine and the easy transfer of test results to electronic medical records (EMR) systems. However, putting these devices on a network also introduces a number of risks.
Is there a brain area for mind-wandering? For religious experience? For reorienting attention? A recent study casts serious doubt on the evidence for these ideas, and rewrites the rules for neuroimaging. Brain mapping experiments attempt to identify the cognitive functions associated with discrete cortical regions.
While the use of ultrasound to identify tumors during kidney cancer surgery is gaining acceptance, a research team at Henry Ford Hospital has successfully taken it a step further by showing an added benefit when the procedure is done robotically.
After a 2011 outbreak of P. aeruginosa, investigators at Beaumont Health System near Detroit, Michigan determined contaminated ultrasound gel was the source of bacteria causing the healthcare-associated infection. The findings emphasize the need for increased scrutiny of contaminated medical products.
In close collaboration with leading clinicians in the field of minimally-invasive medicine, Philips has been driving innovation in interventional imaging for more than 50 years, helping to guide procedures such as the catheter-based treatment of obstructed coronary arteries, brain aneurysms, heart rhythm disorders and defective heart valves.
A new technique for detecting cancer by imaging the consumption of sugar with magnetic resonance imaging has been unveiled by UCL scientists. The breakthrough could provide a safer and simpler alternative to standard radioactive techniques and enable radiologists to image tumors in greater detail.
Varian's Eclipse System Integrates with Elekta Machines for VMAT Treatments at Swiss Cancer HospitalJuly 8, 2013 8:00 am | by PR Newswire | News | Comments
Varian Medical Systems (NYSE: VAR), leader in volumetric modulated arc therapy (VMAT) and radiotherapy treatment planning systems, has successfully integrated its Eclipse™ treatment planning system with Elekta linear accelerators to deliver VMAT treatments at Kantonsspital St. Gallen in Switzerland.
The introduction of CT pulmonary angiography has been associated with an 80% rise in the detection of pulmonary emboli in the US, but with little change in death rates. Professor Renda Soylemez Wiener and colleagues argue this is evidence of overdiagnosis.