Regulatory

Manufactured by Allergan™, “Gummy Bear” breast implants have been used successfully in Europe and Canada for more than a decade. Now they have been cleared for market in the United States.

In the words of 10cc, X-spine is saying “Come on back and do the sacroiliac” as it announces FDA clearance for its new Silex™ SI fixation system. See it and more from the company at this week’s American Association of Orthopaedic Surgeons Meeting in Chicago.

The FDA has issued its highest classification of recall for the Symbios Medical GOPump Elastomeric Infusion PumpKit with and without accessories all containing Dual GOPump, part number 510076. There is a risk that the flow restrictor bead could become dislodged, resulting in a high rate of flow.

Eucomed has joined the campaign trail with its pointedly critical campaign aimed at derailing the tougher measures being proposed by EU regulators. And it has a point, devices being on average 3 years slower to market in the U.S. But we remain unsure as to whether that’s an altogether bad thing.

FDA’s reading material, issued in advance of today’s PMA review meeting are not recommending the approval of the MitraClip implantable heart device, citing a lack of “valid scientific evidence” of safety and effectiveness. And a lack of comparator group.

GelrinC is the first synthetic implant to be CE-approved that is said to provide a customised solution by completely filling cartilage lesions with acellular material. GelrinC is claimed to allow high quality cartilage to regenerate in the knee in the exact shape of the defect.

Adding to its portfolio of embolus-preventing coronary stents, Israeli company InspireMD has now gained CE mark approval for its carotid equivalent which it says holds plaque and thrombus in place against the wall of the blocked artery, preventing debris from falling into the bloodstream and causing a potentially fatal downstream blockage or stroke.

Alphatec Spine, Inc., has received clearance from the U.S. FDA to market and sell its unique and patented Alphatec Solus internal fixation anterior lumbar interbody fusion (ALIF) device.

Vital Images, Inc., a Toshiba Medical Systems Group Company and leading provider of advanced visualization and analysis solutions for healthcare providers, has received FDA 510(k) clearance for its CT TAVR (Transcatheter Aortic Valve Replacement) planning application.

Vital 5, LLC, a VentureMD portfolio company, has received clearance from the U. S. FDA for ReLeaf™, a first-to-market, dual function catheter system that provides simultaneous anesthetic infusion and wound drainage.

Tenaxis Medical®, Inc. Receives FDA Approval for its ArterX® Surgical Sealant (via PR Newswire) MOUNTAIN VIEW, Calif., March 4, 2013 … continue reading “FDA Approval For Tenaxis Medical® ArterX® Surgical Sealant”

Eu regulators have allowed Medtronic to claim one month DAPT requirement in new labelling for its Resolute Integrity drug eluting stent. A timely press release in view of this weekend’s ACC meeting.

Medtronic says its newly CE marked quadripolar leads provide options for physicians to deliver CRT optimally and efficiently. A global clinical study has started enrolling patients in an effort to back up these claims.

CircuLite’s Synergy Minimally-Invasive heart pump is designed to reverse heart failure, thereby filling a treatment gap for ambulatory Chronic Heart Failure patients. The company is hoping a U.S. IDE study will edge the device closer to approval.

VentriPoint Diagnostics has clever dot-based software that can quickly attain right ventricle dimensional data for comparison with a library of heart conditions, thereby assessing patient status. It’s system is already CE marked and is looking close to FDA clearance following the agency’s nod that everything looks in order.

Royal Philips Electronics has announced FDA 510(k) clearance for its MicroDose SI system, the first full-field digital mammography (FFDM) system on the market with the capability to enable future Single-Shot Spectral Imaging applications.