Category: Food & Drug Administration (FDA)
CorMatrix secure FDA clearance for its CanGaroo ECM envelope for use with implantable cardiac devices and touts 1st human use in a patient at Ohio's Cleveland Clinic.
Georgia medical device maker CorMatrix touted an FDA win this month, landing regulatory clearance for its CanGaroo surgical envelope for securing implantable cardiac devices.
Roswell, Georgia – CorMatrix Cardiovascular announced today that it has received U.S. Food and Drug Administration (FDA) clearance to market the CorMatrix CanGaroo ECM Envelope for use with cardiac implantable electronic devices (CIED's) including pacemakers and implantable cardioverter defibrillators (ICD's).
The FDA puts its highest-risk Class I label on the recall of DePuy Synthes' jaw stabilizing system over a defect that may result in injury or death in infants.
FDA regulators put their highest-risk Class I label on the recall of DePuy Synthes' Craniomaxillofacial Distraction System after the company reported 15 injuries associated with the jaw implant.
Florida-based diabetes devices maker Nipro Diagnostics lands FDA clearance for 2 new blood glucose monitors and boosts its manufacturing capabilities ahead of a Q4 2014 launch.
Diabetes company Nipro Diagnostics touted FDA wins for a pair of new blood glucose monitors for use in home and professional settings, saying that the device maker will look to boost its manufacturing capabilities ahead of a late 2014 launch.
Nipro Diagnostics, Inc. announces FDA clearance of its newest blood glucose monitoring systems, True Metrix and True Metrix Pro, and expansion of manufacturing in the USA
FORT LAUDERDALE, Fla. – Nipro Diagnostics, Inc., today announced that the U.S. Food and Drug Administration (FDA) has cleared its True Metrix Self-Monitoring blood glucose system and the True Metrix Pro Professional Monitoring blood glucose system.
FDA regulators approve Medtronic's new Viva CRT-P adaptive cardiac pacemaker for treatment of heart failure or atrioventricular block.
Medtronic (NYSE:MDT) won FDA approval for its Viva CRT-P cardiac resynchronization therapy-pacemaker, which features proprietary software to adjust its pacing parameters to a patient's heart rhythms minute-by-minute.
AdaptivCRT algorithm customizes therapy for heart failure patients and improves their response rates.
MINNEAPOLIS - Medtronic, Inc. (NYSE:MDT) today announced the U.S. Food and Drug Administration (FDA) approval of its newest cardiac resynchronization therapy-pacemaker, Viva® CRT-P, for indicated patients with heart failure or atrioventricular (AV) block.