FDA clears Biotronik’s third-gen injectable cardiac monitor
Biotronik said today that it won 510(k) clearance from the FDA for its Biomonitor III injectable cardiac monitor.
Oswego Lake, Ore.-based Biotronik said the Biomonitor III is 60% smaller than its predecessor and offers increased signal quality and a patient app that reports system diagnostics. The device is approved as MR-conditional for both 1.5T and 3.0T scans.
“Receiving FDA clearance on Biomonitor III further demonstrates Biotronik’s continued dedication to designing innovative technology solutions that improve patient lives,” president Ryan Walters said in prepared remarks. “This device maintains exceptional functionality in detecting arrhythmia and its reduced size and novel delivery tool simplifies the injection procedure. Physicians and patients can count on Biomonitor III to deliver timely and accurate data to identify potentially life-threatening cardiac arrhythmias faster and more confidently than ever before.”
“Biomonitor ICMs have a proven track record for exceptional signal quality,” added Dr. Raul Weiss of Columbus, Ohio. “Biomonitor III expands the existing diagnostic utility of these devices while simplifying the procedure. Biomonitor III is an exceedingly small device with market-leading four year longevity. When physicians are not burdened by poor signal quality, clinically irrelevant data, inaccurate, or worse, missed detections – more time can be devoted to ensuring a timely and accurate diagnosis.”