HeartWare International (NSDQ:HTWR) issued a field notice on its HVAD implantable heart pump over issues with worn alignment guides and connection pins that could lead to the pump stopping, according to the FDA. The FDA labeled it a Class I recall, the most serious type of recall issued by the federal watch dog, indicating that “there is […]
FDA
FH Ortho wins FDA 510(k) clearance for Calcanail
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 […]
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 […]
Peruvian regulators place new requirements on medical devices with PVC components
By Stewart Eisenhart, Emergo Group DIGEMID, Peru’s medical device market regulatory agency, has rolled out new disclosure and laeling rules for medical devices that contain polyvinyl chloride (PVC) or PVC that contains DEHP (di-(2-ethylhexyl)phthalate).
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 […]
Stimwave wins nod from FDA for IDE trial
Stimwave Technologies said yesterday it won FDA investigational device exemption clearance to test an 8-electrode version of its wireless miniature neurostimulator device for the relief of chronic back and leg pain. Miami, Fl.-based Stimwave said the FDA also approved a study of the device using high frequency treatments through an external pulse generator. “This study […]
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. […]
Meeting face-to-face makes all the difference
By Heidi C. Marchand, Pharm.D. While to many, the cherry blossoms in Washington, D.C., signal spring, for my office the season means bountiful opportunities to meet with groups in town for meetings and conventions in our capital city. Patient and health professional advocacy groups that are some of FDA’s key stakeholders come to FDA Headquarters […]
US FDA proposes changes to MedWatch program for healthcare products
By Stewart Eisenhart, Emergo Group US drug and medical device market regulators are proposing changes to voluntary and mandatory post-market reporting forms used by consumers and healthcare providers for adverse events related to medical products.