Regulatory

Fziomed has filed a petition for reconsideration as FDA knocks back its PMA for spinal anti-adhesion barrier gel, Oxiplex. The FDA panel voted 5-2 against approval, citing unconvincing efficacy data from the company’s 352 patient study.

Ethicon Biosurgery, has announced that the U.S. Food and Drug Administration (FDA) has approved EVARREST™ Fibrin Sealant Patch, a novel product that it says rapidly and reliably aids in stopping problematic bleeding during surgery.

The FDA has decided non roller cardiopulmonary pumps will no longer be exempt from the PMA process, meaning that devices like Abiomed’s Impella will have to undergo further steps in order to stay on the market in the long term.

Boston Scientific Corporation has received CE Mark approval and has begun the European market launch of the Precision Spectra™ Spinal Cord Stimulator (SCS) System, the world’s first and only SCS system with 32 contacts and 32 dedicated power sources.

Medtronic, Inc. has gained CE Mark approval for its innovative Sentrino® Continuous Glucose Management System, the first minimally invasive continuous glucose monitoring system specifically designed for use in hospital critical care units.

AliveCor, Inc. has taken the opportunity presented by the 4th annual mHealth Summit in Washington, D.C. to announce the FDA 510(k) clearance and CE marking of its mobile Heart Monitor.

BioVentrix has received CE marking for its clever Revivent™ Myocardial Anchoring System, which makes possible Less Invasive Ventricular Enhancement™ (LIVE™), a procedure that restores the left ventricle from damage done by a heart attack to what the company calls a “more optimal” volume and conical shape.

W.L. Gore has gained CE Mark for the new large diameter 35 mm trunk-ipsilateral leg and 36 mm aortic extender components of the Gore® Excluder® AAA Endoprosthesis expanding the overall treatment range to 19-32 mm.

NeuroMetrix, Inc., a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, has received 510(k) clearance from the U.S. FDA for the disposable electrode that is used in conjunction with its Sensus device.

U.S. device company Bracco Diagnostics has issued a voluntary Class I recall of its Isovue® (iopamidol injection) Pre-Filled Power Injector Syringes. It seems particles have been found in certain lots, with the obvious concern about stroke risk should any of these find there way into the cerebral vasculature.

St. Jude’s CE Mark for its Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds)brings to the market a family of devices featuring new algorithms, designed to help protect patients against inappropriate shocks.

AtCor Medical, the developer and marketer of SphygmoCor® systems, which non-invasively measures central aortic blood pressure and arterial stiffness, has announced that it has received 510(k) marketing clearance from the US FDA for its SphygmoCor® XCEL device.

Very clever inbuilt technology means GE Healthcare’s “FlightPlan For Liver” can help physicians identify which vessels to embolize when isolating liver tumors. The newly approved product is being showcased at Radiology Society Of North America meeting this week.

An orbital sander may sound like a slightly risky thing to be pushing through your average calcified plaque deposit, but following a successful first study, Cardiovascular Systems has now completed enrollment in a second, US-based study in coronary artery patients.

Riverain’s newly CE marked software claims to improves the visual clarity of conventional chest X-ray images and increases radiologists’ efficiency by reducing the time it takes to accurately confirm the proper placement of lifesaving feeding, drug-delivery and pain management tubes and lines.

First NiTiNOL-based intramedullary nail, DynaNail is used successfully in ankle arthrodesis surgery in Chicago