St. Jude Medical, Inc., has seen its MediGuide Enabled™ Ablation Catheters gain U.S. FDA approval. The company is touting reduction in radiation exposure for patients, MediGuide using a previously recorded fluoroscopic map of the target tissue.
Approval/Clearance
FDA Clears Given Imaging’s Next Generation PillCam® SB 3
Improved PillCam SB Technology promises a more detailed and efficient small bowel examination for patients with conditions such as Crohn’s Disease and obscure GI Bleeding. And now it’s FDA approved.
Alere receives FDA Approval for Alere Determine™ HIV-1/2 Ag/Ab Combo
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.
FDA Approves LDR’s Mobi-C Cervical Disc for One-Level Use
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”
FDA Says Wright’s Augment® Bone Graft Not Approvable Based on Study
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.
Stryker Spine’s Venom™ Cannula and Electrode Combination and 11g iVAS® Balloon System Get FDA Nod
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.
FDA Clears Alere™ MobileLink Home Monitoring System
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.
FDA Grants Edwards IDE for US Trial of SAPIEN 3 Transcatheter Valve
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.
Ambio Finds Remote Diabetes Health Monitoring Sweet Spot With FDA Nod
Monitoring specialist Ambio Health, has announced that its wireless remote health and activity monitoring tool, has received Class II FDA 510(k) Clearance.
FDA Clearance for Teleflex ARROW® GPSCath® Balloon Dilatation Catheters in Higher RBP and 80 cm Lengths
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.
FDA Clears Integra’s Titan™ Reverse Shoulder System
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”
FDA Clears Stereotaxis Robotic Navigation and Intracardiac Echocardio Catheter Manipulator
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”
ExAblate Receives Approval of Chinese Food and Drug Administration
Non-invasive MR guided Focused Ultrasound treatment now available for millions of Chinese women suffering from uterine fibroids.
Vagus Nerve Blocking Obesity Treatment on the Road to FDA Approval
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”
FDA Clears Abbott’s FreeStyle Precision Pro Blood Glucose and β–Ketone Monitoring System™
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.
CE Mark for Aurora Spine’s ZIP™ MIS Interspinous Fusion System
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.