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Cell Bio-Systems’ disposable surgical instrument has passed four final tests for biocompatibility, the medical-device developer announced. The completion of the tests clears another hurdle in gaining FDA approval.
Two independent studies concluded that Given Imaging’s PillCam ESO is an accurate, noninvasive alternative to upper endoscopy, the current “gold standard” for evaluating patients, and the most commonly performed procedure in detecting esophageal varices in cirrhotic patients, according to the January issue of Endoscopy.
Texas-based LDR Spine received an investigational device exemption (IDE) from the FDA to conduct clinical trials with its Mobi-C artificial cervical disc, the company announced Feb. 1.
TyRx Pharma has signed an exclusive license agreement with Baylor College of Medicine and The University of Texas M. D. Anderson Cancer Center for the use of the institutions’ patents and associated technologies to develop cardiovascular and surgical medical devices.
The FDA has approved Osteotech’s 510(k) application for the GraftCage ACX device, which is intended to replace a collapsed, damaged or unstable vertebral body in the thoracic or lumbar spine.
The FDA granted Kensey Nash clearance on March 30 to market its TriActiv Embolic Protection System in the U.S. for the prevention of heart attacks during the interventional treatment of saphenous vein grafts (SVGs).
Makers of implantable radio-frequency transponder systems can soon begin marketing their devices without being subject to 510(k) premarket notification requirements, according to an FDA guidance document.
With an aim toward ensuring consistency and understanding between the FDA and clinical trial sponsors, the agency has issued a guidance document addressing general clinical data presentation formats for research studies involving orthopedic implant devices.
In the wake of its recently concluded review of reprocessed single-use devices (SUDs), the FDA last week launched a website detailing the results of the review, including a list of frequently asked questions (FAQ) and a comprehensive register of the devices found not substantially equivalent (NSE).