FH Ortho said today that it won FDA 510(k) clearance for its Calcanail system designed for rear-foot fusion therapy to repair displaced intra-articular fractures of the heel. The system is minimally invasive and uses a nail and cannulated screws to repair rear foot or heel fractures, the Mulhouse, France-based company said. “The Calcanail System allows surgeons to […]
Food & Drug Administration (FDA)
B. Braun’s Aesculap wins FDA nod for lumbar disc
B. Braun Medical subsidiary Aesculap said today that it won FDA approval for its ActivL artificial disc indicated for the treatment of 1-level lumbar degenerative disc disease. The ActivL is designed as an alternative to spinal fusion surgery, the Center Valley, Pa.-based company said, and is the 1st lumbar disc with a mobile ultra high molecular […]
FDA approves St. Jude Medical’s Brio brain implant
(Reuters) — The FDA last week said it approved a brain implant from St. Jude Medical (NYSE:STJ) that helps reduce symptoms of Parkinson’s disease and essential tremor, a neurological disorder that causes rhythmic shaking. The Brio neurostimulation device is an implantable small generator that delivers low intensity electrical pulses to target areas in the brain, according to the […]
Sanovas wins FDA 510(k) clearance for PulmoVia
Sanovas said last week that it won FDA 510(k) clearance for its PulmoVia working channel, part of its platform designed to improve diagnostic and therapeutic interventions in the lung. Working channels are normally integrated into bronchoscopes with optics as 1 piece, but the PulmoVia working channel is separate, CEO Larry Gerrans told MassDevice.com. “We took a […]
Cohera wins FDA EAP designation for Sylys sealant
Cohera Medical said Wednesday it received an expedited access pathway designation for its Sylys surgical sealant. Sylys is a resorbable synthetic sealant designed to help prevent anastomotic leaks during gastrointestinal surgery, the Pittsburgh, Penn.-based company said. Anastomotic leaks occur between sections of surgically joined intestine, and the surgical sealant helps support anastomosis during initial healing to […]
Medical Informatics wins FDA nod for Sickbay system
Medical Informatics Corp. said it won 510(k) clearance from the FDA for its Sickbay clinical platform and patient monitor, patient alarm data and alarm data analytics dashboard applications. SickBay and the associated applications aid in monitoring and managing alarms, the Houston, Texas-based company said. The system provides near real-time viewing of alarms through a web […]
FDA Warns Allergan over Seri scaffold
The FDA warned Allergan last month about marketing the Seri surgical scaffold in the U.S. for breast surgery indications without marketing clearance or approval. An FDA review of Allergan’s Seri website reported the scaffold was being marketted for breast surgery applications, which the federal watchdog says “would constitute a major change or modification to its […]
HeartWare warns on HVAD issues
HeartWare International (NSDQ:HTWR) said today it issued a voluntary urgent medical device correction last month describing 5 complaints about its HVAD implantable heart pump. The 1st issue involves a possible degradation of the HVAD’s internal battery, causing a loss of a “double disconnect alarm” if both power sources that connect to the pump are disconnected, the report said. […]
UPDATE: Baxter recalls Vascu-Guard patches in FDA Class I recall
UPDATED June 5, 2015, with details from the FDA. Baxter (NYSE:BAX) said this week that it’s recalling its Vascu-Guard peripheral vascular patches packaged under 4 specific product codes. The company began notifying customers May 2. The FDA has labeled it as a Class I recall, the most serious type of recall issued by the federal watch […]
Medtech approvals: FDA releases March 2015 PMAs
Summary of PMA Originals & Supplements Approved Originals: 4 Supplements: 69 Summary of PMA Originals Under Review Total Under Review: 61 Total Active: 29 Total On Hold: 32 Summary of PMA Supplements Under Review Total Under Review: 571 Total Active: 417 Total On Hold: 154 Summary of All PMA Submissions Originals: 4 Supplements: 93 Summary […]
FDA warns Insightra on adverse event reports
The FDA warned Insightra Medical last month about how it handles reporting and investigating failure complaints concerning its intra-aortic balloon catheters. An FDA investigator inspected Insightra’s Irvine, Calif., facility in February and issued a Form 483 detailing the company’s failure to adequately establish procedures for receiving, reviewing, and evaluating complaints, according to a May 21 […]