News
Stryker And DePuy Pinnacle Hip Lawsuit Settlement News Update
May 16, 2013 6:00 am | by PR Newswire | CommentsLegal-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Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A - Draft Guidance for Industry and Food and Drug Administration Staff
May 16, 2013 12:00 am | by U.S. Food & Drug Administration | CommentsThis draft guidance document provides CDRH proposed interpretation of key provisions of Section 517A of the Food, Drug and Cosmetic Act (FD&C Act), which was added by section 603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 Staff
May 16, 2013 12:00 am | by U.S. Food & Drug Administration | CommentsThis 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."
CCS Medical Moves Forward as Medicare Winner
May 15, 2013 6:26 pm | by PR Newswire | CommentsFARMERS 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.
GE Healthcare Unveils Exclusive Imaging Technology for Joint Replacements and Implanted Devices
May 15, 2013 4:33 pm | by Business Wire | CommentsAt 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.
Life After Failing TVM Treatments is a Rollercoaster of Side Effects for Women
May 15, 2013 3:07 pm | by PR Newswire | CommentsCONCORD, 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...
CircuLite® Receives Approval to Begin CE Mark Trial for SYNERGY® IC Circulatory Support System
May 15, 2013 12:18 pm | by The Associated Press | CommentsTEANECK, 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 Launches Industry's Highest Resolution HD+ Imaging Technology for Flexible Endoscopy
May 15, 2013 12:12 pm | by PENTAX Medical Company | CommentsPENTAX 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.
Body Fat Hardens Arteries After Middle Age
May 15, 2013 11:32 am | by Sam Wong, Imperial College London | CommentsHaving 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.
New Blood Test Finds Allergies Before Implant Surgery
May 15, 2013 11:19 am | by National Jewish Health | CommentsA 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."
ACell MatriStem Technology Ranks Highest in Constructive Remodeling
May 15, 2013 11:01 am | by The Associated Press | CommentsACell, Inc., a leading developer of next-generation regenerative medicine products, announced today that its MatriStem medical devices demonstrate the highest constructive remodeling response in a recent study comparing 14 extracellular matrices (ECM) designed to aid in surgical procedures. ...
Engineered Biomaterial Could Improve Success of Medical Implants
May 15, 2013 10:22 am | by Michelle Ma, University of Washington | CommentsIt’s a familiar scenario – a patient receives a medical implant and days later, the body attacks the artificial valve or device, causing complications to an already compromised system. Expensive, state-of-the-art medical devices and surgeries often are thwarted by the body’s natural response to attack something in the tissue that appears foreign.
MiE's PET SCINTRON Receives FDA Approval
May 15, 2013 9:51 am | by Bio-Medicine.Org | CommentsHOUSTON , May 15, 2013 /PRNewswire-iReach/ -- Medical Imaging Electronics (MiE) and Nuclear Imaging Services (NIS) are pleased to announce that the ECAT Scintron has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). MiE along with NIS will showcase this product at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting in Vancouver, BC , Canada Ju...
Cardica Completes Enrollment In European Clinical Trial For Surgical Cutting And Stapling Device
May 15, 2013 8:00 am | by The Associated Press | CommentsCardica, Inc. (Nasdaq: CRDC) today announced it has completed enrollment in the European clinical study for its MicroCutter XCHANGET 30, a cartridge-based cutting/stapling device with a 5-millimeter shaft diameter and cross-sectional area more than six times smaller than standard...
ApoCell Announces Delivery of First Prototypes of ApoStreamT Circulating Tumor Cell (CTC) Isolation Technology to National Cancer Institute
May 15, 2013 8:00 am | by The Associated Press | CommentsApoCell, Inc. announced that the first prototypes of its ApoStreamT circulating tumor cell (CTC) isolation system have been delivered to select investigator sites including SAIC-Frederick Inc. (SAIC-F) in support of the National Cancer Institute (NCI). The delivery is part of a $2.9 million ...
