Category: Cardiac Rhythm Management
The FDA grants a humanitarian device exemption for a micro-pacemaker designed to be implanted in a fetus.
Comparative sizes of fetal
and adult pacemakers.
Click image to enlarge.
Researchers at Children's Hospital Los Angeles and the University of Southern California said the FDA granted a humanitarian device exemption for the fetal micro-pacemaker they designed.
The FDA's approval of Boston Scientific's Emblem S-ICD prompts Wells Fargo to downgrade St. Jude Medical, saying Boston Scientific is poised to take share in the cardiac rhythm management market.
Biotronik says it won pre-market approval from the FDA for its Eluna MRI-safe pacemaker.
Biotronik said today that the FDA approved its ProMRI Eluna MRI-safe pacemaker, making it the only company with single- and dual-chamber MRI-safe pacemakers on the U.S. market.
Boston Scientific says it won CE Mark approval in the European Union and FDA approval for its newest 'leadless' implantable cardiac defibrillator, the Emblem S-ICD.
Europe's top court rules that Boston Scientific must cover the cost of replacing defective pacemakers.
Cyberonics agrees to an all-stock acquisition of Italian medical device maker Sorin that's worth about $1.4 billion.
German cardiac device-maker Biotronik says 2 studies have confirmed its ProMRI pacemaker systems are safe to use with certain MRI procedures.
German cardiac device-maker Biotronik announced that 2 studies have confirmed its ProMRI pacemaker systems are safe to use with certain MRI procedures.
The studies tracked 226 patients with ProMRI Evia/Entovis SR-T and DR-T pacemaker systems for up to 1 month after they received MRI scans of either the head or lower lumbar region. Neither study reported any serious adverse events.