Federal prosecutors yesterday said Biotronik agreed to pony up $4.9 million, but admitted no wrongdoing, to settle allegations that it ran a kickbacks scheme to induce physicians to use its cardiac rhythm management devices.
Home-based heart monitoring could help save lives while reducing the cost of follow-up care for patients with heart failure, according to a new study.
Oregon-based heart devices maker Biotronik touted FDA approval to expand its ProMRI clinical trials, permitting the company to enroll patients with implantable cardioverter defibrillators for full-body MRI scanning.
A string of presentations and poster sessions during this week’s Heart Rhythm conference pitted device makers against each other in the battle for battery superiority.
MASSDEVICE ON CALL — Oregon-based Biotronik said it won FDA approval for its Entovis pacemaker system with ProMRI technology, the latest in MRI-friendly pacing systems approved for the U.S.
The Entovis is the 1st FDA-approved MRI-friendly pacemaker with both single- and dual-chamber pacing options, Biotronik said. The company added that it’s the 1st worldwide to couple MRI-safe pacing with current-generation leads.
Biotronik won European regulatory approval for its Passeo-18 Lux drug releasing balloon and the company is beginning commercial efforts in all CE Mark countries.
Biotronik said it inked a deal to provide cardiac rhythm management devices to the 8 million veterans served by the U.S. Veterans Affairs Dept.
The Berlin-based company makes cardiac resynchronization therapy defibrillators and endovascular medical devices.