New Injectable Cardiac Monitor Receives FDA Clearance

By Dave Quaile, /alert Contributor
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The FDA has granted clearance to the BIOMONITOR III injectable cardiac monitor, according to a press release from the manufacturer, Biotronik.

The BIOMONITOR III injectable cardiac monitor may enable timely diagnosis and appropriate treatment by documenting suspected arrhythmia or unexplained syncope with increased clarity.

“BIOMONITOR III expands the existing diagnostic utility of these devices while simplifying the procedure,” Raul Weiss, MD, professor of clinical medicine and director of Electrophysiology Fellowship Program at The Ohio State University Medical Center, said in the release. “BIOMONITOR III is an exceedingly small device with market-leading four-year longevity.”


Heartbeat illustration. Source: Getty

According to the release, AF contributes to more than 130,000 deaths each year and the death rate from AF has risen for more than two decades although up to 80% of strokes in people with AF can be prevented. Early detection of arrhythmia through ICMs, such as the BIOMONITOR III enable physician intervention before occurrence of adverse outcomes. 

The BIOMONITOR III ICM is 60% smaller than its predecessor and comes pre-loaded in an injection tool with no assembly required, which may significantly simplify the insertion process.

The ease of use, single-piece injection tool is designed for a variety of clinical settings, including office-based procedures. BIOMONITOR III supports reduced case times and lower procedural costs, according to Biotronik. 

The new injectable cardiac monitor may help to improve accuracy of arrhythmia detection and diagnosis by offering signal quality, according to Weiss

“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,” he said.

A patient app has also been developed to encourage patient-provider engagement. The app is designed to report system diagnostics and offers a method for patients to annotate symptoms with automatic synchronization to Biotronik Home Monitoring.

The device features Intelligent Memory Management to preserve and deliver the most relevant detections and improve workflow performance, as well as a home monitoring system for injectable cardiac monitor devices. 

According to the release, the monitor is approved as MR conditional for both 1.5T and 3.0T applications.

“This device maintains exceptional functionality in detecting arrhythmia and its reduced size and novel delivery tool simplifies the injection procedure,” Biotronik President, Ryan Walters, said in the release. “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.”

Disclosure: Walters is an employee of Biotronik. Weiss reports receiving grants and research support from Biosense Webster, Biotronik, Boston Scientific Medtronic and St. Jude as well as consultant fees from Biosense Webster, Biotronik, Boston Scientific and Merit Medical.