Regulatory

Cordis and the FDA have notified healthcare professionals and their organizations of a product labeling correction to provide clarification and additional information to minimize likelihood of implanting the company’s Optease Vena Cava filter backwards.

The U.S. FDA has cleared Stryker Interventional Spine’s Venom RF Cannula and Venom Electrode, designed to provide an effective and minimally invasive treatment for facet joint pain. Stryker says the 11g iVAS Balloon System addresses the surgical trend of shifting toward less invasive treatment options.

Cardium Therapeutics has filed a new 510(k) submission for its current FDA-cleared Excellagen® advanced wound care product to reflect additional and specific structural and functional properties of the product.

Alere™ Connect has been granted FDA 510(k) market clearance for the Alere™ MobileLink. The new product offering is one of Alere’s connected device technologies designed to empower patients by allowing self-testing at home and delivering data quickly and seamlessly to clinical systems accessed by their healthcare providers.

Transcatheter valve pioneer, Edwards Lifesciences Corporation has received conditional Investigational Device Exemption approval from the U.S. FDA to initiate a clinical trial of its new Edwards SAPIEN 3 transcatheter aortic heart valve and accessories.

Monitoring specialist Ambio Health, has announced that its wireless remote health and activity monitoring tool, has received Class II FDA 510(k) Clearance.

Back in June Teleflex, Inc., saw its Arrow® GPSCath® Balloon Dilatation Catheter CE marked. Now the company tells us it has received U.S. FDA 510(k) clearance to market the devices in Higher Rated Burst Pressure (RBP) and 80 cm lengths.

Integra LifeSciences Holdings Corporation has announced that the Integra® Titan™ Reverse Shoulder System has received 510k clearance from the U.S. FDA. … continue reading “FDA Clears Integra’s Titan™ Reverse Shoulder System”

Stereotaxis, Inc. has been granted FDA 510(k) clearance to market its Vdrive™ Robotic Navigation System with V-Sono™ Intracardiac Echocardiography (ICE) … continue reading “FDA Clears Stereotaxis Robotic Navigation and Intracardiac Echocardio Catheter Manipulator”

The Monarch eTNS System safely stimulates branches of the trigeminal nerve through the skin. In clinical trials, eTNS has been found to substantially reduce seizures in patients with epilepsy and reduce symptom severity in patients with depression, PTSD and ADHD. Now an IDE study is to start in the US.

Non-invasive MR guided Focused Ultrasound treatment now available for millions of Chinese women suffering from uterine fibroids.

EnteroMedics Inc., has developed neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders.  In a move that is … continue reading “Vagus Nerve Blocking Obesity Treatment on the Road to FDA Approval”

Abbott has announced that it has received U.S. FDA clearance for its FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System™, which it describes as an advanced blood glucose monitoring system designed to address the key needs of hospital customers.

US device regulatory agency the FDA has issued a Class I recall, it’s highest category recall, for the LeMaitre Vascular Albograft Vascular graft, for the reason that it may leak from its surface following implantation. The same product was the subject of recall activity in Europe in March 2012, due to reports of profuse bleeding through the wall of the graft.

Aurora Spine has now received the CE Mark Approval for its ZIP™ MIS Interspinous Fusion System, meaning it can now be sold in the European Union and other countries that recognize or require this approval.

Dallen Medical has announced that it has submitted an FDA 510(k) application as it seeks clearance for its proprietary Tensyn™ Band for syndesmosis repair.