Products

Diagnostics company Alere Inc., has announced today that it has received U.S. FDA approval of its pre-market application to market Alere Determine™ HIV 1/2 Ag/Ab Combo in the United States for the detection of HIV-1 p24 antigen and antibodies to HIV-1/HIV-2.

Spinal technology company LDR, offers exclusive spinal implant technologies for both non-fusion and fusion applications. Now the company has announced … continue reading “FDA Approves LDR’s Mobi-C Cervical Disc for One-Level Use”

Wright Medical Group, Inc. has announced it received a “not approvable” letter from the FDA in response to its Pre-Market Approval application for Augment® Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion procedures.

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.

Medtech market intelligence company Millennium Research Group, reckons demand for arthroscopy procedures will grow steadily in the United States through 2021, supported by the ageing population and increasing obesity rates. With procedural growth will come growth in the associated devices.

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”

Polymer Technology Systems, Inc. has introduced the CardioChek Plus analyzer at the annual American Association for Clinical Chemistry (AACC) in Houston. The device is a combination reflectance lipid and electrochemical glucose analyzer that delivers rapid test results for lipids and glucose simultaneously.

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.