CorMatrix Cardiovascular said today it won FDA 510(k) clearance for its Tyke biomaterial for use in neonates and infants. The patch is designed to repair pericardial structures and as an epicardial covering or for intracardiac defects, septal defects, annulus repair, suture-line buttressing. The Tyke is derived from the company’s ECM technology platform and is composed […]
Food & Drug Administration (FDA)
FDA wants answers from Medtronic, St. Jude on leadless pacers
The FDA is hosting a panel meeting on leadless pacemaker devices, looking to St. Jude Medical (NYSE:STJ) and Medtronic (NYSE:MDT) to join the discussion and make recommendations on acceptable guidelines on the devices. The panel committee will seek recommendations on clinical trial and post approval study design and physician training, and will be asked to make recommendations […]
Spectranetics wins FDA nod for Bridge occlusion balloon
Spectranetics (NSDQ:SPNC) said today it won FDA 510(k) clearance for its Bridge occlusion balloon designed to temporarily occlude vessels during cardiac lead extraction procedures. The Colorado Springs, Colo.-based company’s Bridge balloon is designed to reduce blood loss in the event of a tear and to provide a “bridge” to surgical intervention. “The Bridge occlusion balloon […]
Cartiva, Angel Medical win FDA PMA review dates
The FDA set dates with Cartiva and Angel Medical to review premarket approval applications for Cartiva’s Synthetic Cartilage Implant and Angel Medical’s Guardian cardiac monitor system, the companies said today. Alpharetta, Ga.-based Cartiva is slated to meet with the federal watchdog on April 20, to review the application for its SCI, which is designed to treat osteoarthritis […]
FDA approves Medtronic’s Amplia, Compia MRI-safe CRT-Ds
Medtronic (NYSE:MDT) today claimed title to being to only company with cardiac resynchronization therapy defibrillators approved by the FDA for MRI scans. The Fridley, Minn.-based medical device giant said the FDA approved its Amplia and Compia MRI Quad CRT-D SureScan devices for MRI scans on any part of the body without positioning restrictions. Medtronic plans to […]
Medtronic wins expanded PMA for CoreValve
The FDA cleared expanded indications for Medtronic‘s (NYSE:MDT) CoreValve TAVR devices, now cleared for use in patients with end-stage renal disease and those with low-grade, low-flow aortic stenosis. Medtronic won approval from the FDA to modify the CoreValve’s labeling in November which included both its CoreValve and CoreValve Evolut R systems. The changes to the labeling […]
Report: Independent reviewer gives FDA pass on review program improvements
On Monday, the FDA said it got a passing grade from an independent assessment group evaluating changes implemented to improve its review process management system starting in 2014. The changes were based on recommendations given as part of a separate individual assessment, performed by Booz Allen Hamilton, which was performed as part of the Medical […]
Medtech approvals: FDA releases December 2015 PMAs
The Food & Drug Administration today released a list of pre-market approvals granted in December 2015: Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 81 Summary of PMA Originals Under Review Total Under Review: 58 Total Active: 32 Total On Hold: 26 Summary of PMA Supplements Under Review Total Under Review: 599 Total […]
FDA clears Hansen’s Magellan eKit for 3rd-party caths
Hansen Medical (NSDQ:HNSN) said today it won FDA 510(k) clearance for its Magellan Robotic Catheter eKit which allows operators to control 3rd party microcatheters through the robotic system. The approval comes at least partly based on cases performed with the eKit during the Embolization Procedures in Peripheral Vasculature clinical study, Mountain View, Calif.-based Hansen Medical said. […]
LivaNova wins FDA nod for Crown PRT stented heart valve
LivaNova (NSDQ:LIVN) said today it won FDA premarket approval for its Crown PRT stented aortic heart bioprosthesis for treating aortic valve disorder. The Crown PRT is designed for aortic valve replacements and features optimized hemodynamics and phospholipid reduction treatment designed to improve valve durability, LivaNova said. “Crown PRT is a modern bioprosthesis enabling a simple, safe, […]
Medtronic, St. Jude amongst firms to present data at FDA leadless pacer meeting
Medtronic (NYSE:MDT) and St. Jude Medical (NYSE:STJ) are among medtech firms who have said they will present data on their leadless pacing systems, the Micra and Nanostim, at an FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee. The panel is meeting on Feb. 18 in Gaithersburg, Md. to discuss leadless cardiac pacemaker device technology […]