USA

FDA approves cardiac ablation products from St Jude.

MacMillan leaves Stryker with immediate effect for personal reasons.

Covidien’s stent-like clot retrieval device, SOLITAIRE FR, worked well enough in this randomised study to persuade the safety monitoring committee to end the trial early.

Scientists at Berkeley have decoded the imagined speech of a patient in what could be a breakthrough in understanding and utilisation of brainwaves in speech impaired patients.

Vascular specialist AngioDynamics, has announced it has agreed to acquire Navilyst Medical in a transaction valued at $372 million.

Medtronic gets a little closer to market (in USA) with the announcement that CoreValve’s extreme risk group enrollment is now complete.

Abstract Yet again the CE vs FDA debate is brought into sharp relief with the news that Cohera Medical has … continue reading “FDA Allows CE Marked Glue In On “Investigational Device” Basis”

Stryker Corporation has announced that it’s Biotech division has reached a settlement with the U.S. Attorney’s Office for the District of Massachusetts, agreeing to pay a non-tax deductible fine of $15 million for one misdemeanour. Thirteen other felony charges will be dismissed.

Two years after receiving its “equivalent” CE mark approval, W L Gore has now announced an extension of the indications for use of its Conformable Gore TAG endoprosthesis to include traumatic aortic transections.

FDA warns DePuy about the use of custom device exemption to allegedly supply devices that don’t fit FDA’s definition of custom. DePuy then ceases manufacturing all custom devices.

Biomet, Inc., has announced FDA clearance of two new products; the E1® humeral bearing for use with the Comprehensive® Reverse Shoulder System, and the Comprehensive® Segmental Revision System.

Results from the St Jude sponsored ASSERT study has found that pacemaker patients who have no history of atrial tachycardia (AT) or AF, but do have device-detected arrhythmias, are approximately 2.5 times more likely to have a stroke than patients who do not have device-detected arrhythmias.

Despite a generally gloomy outlook Stryker financials and predictions for 2012 look strong from preliminary report.

Ortho Kinematics Inc has announced FDA clearance for its KineGraph VMA system. The company aims to replace the flexion/extension x-ray method of detecting spinal dysfunction

Heartwire (theheart.org) has reported on a study summarising “real-world” experiences with AF Ablation and found patient factors and hospital procedure volume to be determinants of post-operative complications and rehospitalisation.

TriReme Medical, Inc.has received 510(K) FDA approval to market its “Chocolate” PTA balloon catheter for the treatment of occluded peripheral arteries in the United States.