Category: Food & Drug Administration (FDA)Syndicate content

DePuy Synthes gets FDA's highest-risk warning after 15 complaints

August 27, 2014 by Arezu Sarvestani

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.

DePuy Synthes recalls orthopedic implant, gets FDA's highest-risk warning

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.

Diabetes: Nipro Dx boosts manufacturing following FDA wins for blood glucose monitors

August 25, 2014 by Arezu Sarvestani

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: Nipro Dx boosts manufacturing following FDA wins for blood glucose monitors

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.

Press Release: Nipro Diagnostics, Inc. announces FDA clearance of its newest blood glucose monitoring systems

August 25, 2014 by MassDevice

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

Press Release: Nipro Diagnostics, Inc. announces FDA clearance of its newest blood glucose monitoring systems

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.

Medtronic's personalized pacemaker wins FDA approval

August 25, 2014 by Arezu Sarvestani

FDA regulators approve Medtronic's new Viva CRT-P adaptive cardiac pacemaker for treatment of heart failure or atrioventricular block.

Medtronic's personalized pacemaker wins FDA approval

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.

Press Release: Medtronic Viva cardiac resynchronization therapy-pacemaker now available in U.S.

August 25, 2014 by MassDevice

AdaptivCRT algorithm customizes therapy for heart failure patients and improves their response rates.

Press Release: Medtronic Viva cardiac resynchronization therapy-pacemaker now available in U.S.

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.

Report: Amazon may be eying healthcare, too | MassDevice.com On Call

August 25, 2014 by Arezu Sarvestani

Speculation arises after FDA reports reveal that leaders from online retailer Amazon took meetings with the federal watchdog agency.

MassDevice.com On Call

MASSDEVICE ON CALL — Another tech giant may be about to jump into the healthcare space.

Modern Healthcare reported that "leaders" from online retailer Amazon took a meeting last month with the FDA's global regulatory operations & policy deputy commissioner, Howard Sklamberg, as well as other agency officials. The paper noted the meeting in one of the FDA's recent calendar updates.

Intuitive Surgical wins FDA OK for Firefly imaging

August 21, 2014 by Arezu Sarvestani

All new da Vinci systems will ship with Intuitive Surgical's newly cleared Firefly blood and tissue imaging technology.

Intuitive Surgical wins FDA OK for da Vinci imaging feature
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