SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that world-renowned heart surgeon and SynCardia co-founder Jack G. Copeland, MD, was awarded the prestigious Pioneer in...
St. Jude Medical Announces European Approval of 3-D Vessel Reconstruction Technology to Aid Physicians in Stent PlacementMay 16, 2013 8:01 am | by The Associated Press | Comments
ST. PAUL, Minn.--(BUSINESS WIRE)--May 16, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE Mark approval of its ILUMIEN ™ OPTIS ™ PCI Optimization System ™, a new technology designed to provide physicians with a comprehensive disease assessment tool for...
American Association for Cancer Research CEO Recognized With Prestigious Award From Fox Chase Cancer CenterMay 16, 2013 8:00 am | by AACR | Comments
PHILADELPHIA — Margaret Foti, Ph.D., M.D. (h.c.), chief executive officer (CEO) of the American Association for Cancer Research (AACR), was honored with the 2013 Stanley P. Reimann Honor Award for her deep and far-reaching contributions to cancer science and medicine at a celebration hosted by Fox Chase Cancer Center, held last night in Philadelphia, Pa.
Biosensors International Group, Ltd., a developer, manufacturer and marketer of innovative medical devices, announced on May 13, 2013 that it has entered into an agreement to acquire substantially all assets of Spectrum Dynamics, a leader in advanced functional assessment technologies, including those used to evaluate patients for cardiac interventions, subject to the fulfillment of certain conditions.
Legal-Bay LLC, the Lawsuit Settlement Funding Company, has issued an update on two major hip implant litigations in the mass tort market. And the results are completely different. Legal-Bay believes the Stryker hip litigation on the ABG II and the Rejuvenate which have been already recalled by the company will see a smoother road for plaintiffs looking for a settlement in the not so distant future.
Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A - Draft Guidance for Industry and Food and Drug Administration StaffMay 16, 2013 12:00 am | by U.S. Food & Drug Administration | Comments
This draft guidance document provides CDRH proposed interpretation of key provisions of Section 517A of the Food, Drug and Cosmetic Act (FD&C Act), which was added by section 603 of the FDA Safety and Innovation Act (FDASIA) of 2012, as those provisions..
Center for Devices and Radiological Health Appeals Processes - Guidance for Industry and Food and Drug Administration StaffMay 16, 2013 12:00 am | by U.S. Food & Drug Administration | Comments
This guidance document describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees. This guidance supersedes “Medical Device Appeals and Complaints: Guidance for Dispute Resolution,” and “Resolving Scientific Disputes Concerning The Regulation of Medical Devices, A Guide to Use of the Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA."
UCB and IBM today announced the completion of the initial phase of a project designed to harness the power of analytics to help healthcare providers deliver more highly personalized care to people living with epilepsy. The milestone marks the critical first step in the path towards eventually harnessing the transformative power of cognitive computing capabilities, such as IBM Watson, for epilepsy care.
FARMERS BRANCH, Texas, May 15, 2013 /PRNewswire/ -- Effective July 1, CCS Medical, a leading provider of home delivery medical equipment and supplies, will be one of only 18 Medicare mail order suppliers providing diabetic testing supplies nationwide.
At an event held at Hospital for Special Surgery, GE Healthcare introduced MAVRIC SL, a novel magnetic resonance imaging technique designed to address the growing clinical need to more accurately image soft tissue and bone in patients with MR Conditional-labeled implants, such as joint replacements and other instrumentation.
CONCORD, Calif., May 15, 2013 /PRNewswire/ -- Imagine what it would feel like to have a cheese grater wearing at your tissue every time you moved. For women with transvaginal mesh (TVM) implants this stomach wrenching analogy can hit home all too closely. Complications from the surgical...
TEANECK, N.J.--(BUSINESS WIRE)--May 15, 2013--CircuLite®, Inc. today announced that it has received approval from the Federal Agency for Medicines and Health Products in Belgium to commence the CE Mark trial of the SYNERGY® IC Circulatory Support System, the first mechanical support system that...
PENTAX Medical Company, a healthcare industry leader in endoscopic imaging, announces the U.S. launch of the EPK-i®5010 Video Processor with PENTAX i-SCAN™, the industry's highest* resolution HD+ imaging technology for flexible endoscopy.
Having too much body fat makes arteries become stiff after middle age, a new study has revealed. In young people, blood vessels appear to be able to compensate for the effects of obesity. But after middle age, this adaptability is lost, and arteries become progressively stiffer as body fat rises – potentially increasing the risk of dying from cardiovascular disease.
A growing number of patients learn of allergies to new hips and knees only after surgery is done. Imagine what Paula Spurlock must have been going through. Shortly after having a hip replaced in 2011, the trouble started. "I had horrible itching, really bad migraines and intense pain throughout my body," she said. "I couldn't take it. Every single thing in me itched."