Regulatory

Canadian company CellAegis Devices, Inc., has announced that it has received a CE Mark for its autoRIC™ Device, which the company says for the first time allows simple, consistent, reliable and cost-effective automation of remote ischemic conditioning at the point of care.

Carefusion is clearly busy with recall issues, three ventilator products having suffered problems in the past year (two in the past month). the company is now updating its guidance on the Enve® recall issued in June.

Crux Biomedical has announced FDA clearance for its novel Vena Cava Filter which uniquely features bi-directional retrieval via either the femoral or jugular vein access.

UK medical device regulatory authority the MHRA has issued a Medical Device Alert pertaining to the Ankle Evolutive System prosthesis from French company Transystème-JMT Implants. Evidence has been mounting for a while, which raises the question of whether regulatory oversight was adequate.

Xlumena, Inc. has announced that it has received CE Mark approval to market its AXIOS Stent and Delivery System for biliary tract drainage. The device was previously approved for the treatment of pancreatic pseudocysts.

TriReme Medical, Inc. has announced that it has received FDA clearance for an expanded matrix of sizes for its unique Glider PTCA balloon catheter. Glider is now approved for the treatment of lesions in the coronary vasculature in balloon diameters from 1.5 3.5mm and in lengths from 4mm to 20mm.

Imaging specialist Olea Medical, has obtained FDA 510(k) clearance to market its Olea Sphere medical imaging enterprise software package in the US.

U.S Regulatory Agency the FDA is issuing guidelines under which it will give medical device makers feedback before they submit a product- or research-specific application.

Kimberly-Clark Health Care has announced that it has received FDA 510(k) clearance for its KIMGUARD ONE-STEP portfolio with one-year maintenance of package integrity for KC300 to KC600 for Pre-vacuum Steam and Ethylene Oxide.

Israeli company BioControl Medical has announced U.S. FDA approval to begin the second phase of INOVATE-HF (INcrease Of VAgal TonE in Heart Failure), a global, multi-centre, investigational device exemption (IDE) clinical study of the company’s CardioFit® system for heart failure.

Flexible Stenting Solutions inc., has announced receipt of FDA 510(k) clearance for an increased range of sizes of its FlexStent® Biliary Self-Expanding Stent System, including 9 and 10 mm diameters in lengths up to 100 mm.

In one of life’s pleasing little coincidences a newly published meta-review of wound care studies has, among its conclusions, established that topical honey reduces wound healing time when compared to film or gauze-based dressings for burns. Derma Sciences, Inc., with perfect timing has announced the CE Marking for its patented MEDIHONEY® HCS (hydrogel colloidal sheet) dressings, containing (you’ve guessed it), honey.

The US FDA is proposing to establish a system which would require the label of most medical devices and device packages to include a unique device identifier in an endeavour to identify potential problems earlier and better isolate affected populations.

9 patient deaths are reportedly linked with catheter entrapment when delivering Covidien subsidiary ev3’sOnyx injectable embolic material into the brain. FDA has seen fit to warn users of the potential for this to occur.

In this guest editorial, submitted by John Martin of legal marketing specialist firm eJustice, he reports on FDA’s most recent review of the ongoing all-metal hip debacle.

Integrity Life Sciences has somewhat belatedly announced FDA 510(k) clearance for its Integrity Spinal Care System. In a press release, issued this week, the company says it gained clearance on April 5th, 2011.