FDA clears Biotronik’s next-gen injectable cardiac monitor

Biotronik on July 8 announced its BIOMONITOR III injectable cardiac monitor (ICM), a diagnostic tool designed to document suspected arrhythmias, has been cleared by the FDA.

The BIOMONITOR III device is 60% smaller than its predecessor and comes pre-loaded in an injection tool, facilitating the ICM insertion process. The single-piece injector can be easily used in clinical settings, according to a release, and Biotronik says it supports reduced case times and lower procedural costs in patients with suspected arrhythmias or unexplained syncope.

“BIOMONITOR ICMs have a proven track record for exceptional signal quality,” Raul Weiss, a physician in Columbus, Ohio, said in a statement. “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.”

BIOMONITOR III goes hand-in-hand with a patient app that aims to support patient-provider engagement, according to Biotronik’s release. The app reports system diagnostics and allows patients to annotate their symptoms in real time.

The device has been approved by the FDA as MR-conditional for both 1.5T and 3.0T applications.