Two implanted heart devices used by patients in end-stage heart failure are now under a strict U.S. Food and Drug ...
Opens in a new tab or window LOS ANGELES -- Clinicians working in advanced heart failure ... shrinking number of device therapies left from round after round of FDA recalls. Could a changed ...
Philips is recalling the software associated with its mobile cardiac outpatient telemetry devices after 109 patient injuries and two patient deaths, a Jan. 13 FDA recall notice said. The software ...
Hologic issued a notice of possible health risks linked to its BioZorb Marker and BioZorb LP Marker implantable devices in February and initiated a recall in March. The FDA categorized the recall ...
A national clinical trial is underway to compare a novel mechanical heart pump to the only device currently used to treat end-stage heart failure. The INNOVATE study, led by University of Michigan, wi ...
The update comes about six weeks after an early alert flagged reports of 120 injuries and one death linked to reprocessing of ...
A new high-tech help for young heart ... Drug Administration. Doctors say this will allow them to save more lives, an important milestone as we kick off American Heart Month. It's a little device ...
The recall affects devices used for pediatric patients weighing less than 10 kg. Customers who own Mercury Medical ventilator products are urged to visit the FDA website to determine whether their ...