The appeal, or petition for reconsideration, is a rarely used part of the PMA process that companies can pursue when their device application is denied by one of the centers within FDA. As part of the appeals process, CDRH issued a denial letter, which EES received on October 26, 2010. The next step is for [...]

Hospira Symbiq One and Two Channel Infuser Recall Class: I Date Recall Initiated: February 22, 2010 Products: Symbiq Infusion System Brand Name: Symbiq One-Channel Infuser Symbiq Two-Channel Infuser Model Numbers: 16026 Symbiq One-Channel Infuser 16027 Symbiq Two-Channel Infuser The affected units were distributed from December 23, 2006 to January 22, 2010. All lots are affected [...]

MINNEAPOLIS–(BUSINESS WIRE)–Medtronic, Inc. (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) has classified the company’s previous action related to the Octopus Nuvo Tissue Stabilizer as a Class I recall. FDA classifies a recall as Class I when the agency believes that there is a reasonable probability that use of the recalled product [...]

NEW YORK–(BUSINESS WIRE)–Small Bone Innovations, Inc. (SBi), a leading, privately-held orthopedics company focused exclusively on technologies and treatments for the small bones & joints, announced that it has received 510(k) pre-market clearance notifications from the U.S. Food and Drug Administration (FDA) for Mini-Rail Fixation System (‘Mini-Rail System’) and large Cannulated Screw System for use in [...]

WASHINGTON, Feb. 24 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration and the National Institutes of Health today unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients. The initiative involves two interrelated scientific disciplines: translational science, the shaping of basic scientific discoveries into [...]

Federal regulators sent Lynn Cooper quite a birthday gift last month. U.S. Food and Drug Administration officials called Cooper on Jan. 28, her 55th birthday, while she was at a Florida medical conference, notifying her that they had approved a new surgical headlamp technology for BFW Inc. Cooper, who is CEO of BFW, and Allen Kirschenbaum, [...]