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July 9, 2019

Biotronik gets FDA approval for injectable cardiac monitor

Medical technology company Biotronik has received US Food and Drug Administration (FDA) clearance for its injectable cardiac monitor (ICM), BIOMONITOR III.

Medical technology company Biotronik has received US Food and Drug Administration (FDA) clearance for its injectable cardiac monitor (ICM), BIOMONITOR III.

The next-generation cardiac monitor, which is 60% smaller than its predecessor, is intended to provide information on suspected arrhythmia or unexplained syncope with increased clarity.

It is expected to allow quick diagnosis and appropriate treatment and is available pre-loaded in an injection tool.

To simplify the insertion process, BIOMONITOR III does not require assembly. The single-piece injection design is meant for easy usage in different clinical settings, including office-based procedures.

The device is said to provide improved signal quality for more accurate arrhythmia detection and diagnosis.

In addition, the cardiac monitor comes with an app for patient-provider engagement. The app provides information on system diagnostics and enables patients to annotate symptoms.

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Biotronik president Ryan Walters said: “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.”

The new ICM integrates an Intelligent Memory Management capability that helps to document and deliver the most relevant detections.

It is integrated with the company’s fully automatic, daily remote monitoring system BIOTRONIK Home Monitoring for ICMs.

Additionally, BIOMONITOR III features a lossless compression algorithm to ensure high amplitude signal quality through the Home Monitoring system.

The device secured approval as MR conditional for 1.5T and 3.T applications.

In March this year, the company secured the FDA approval for Acticor and Rivacor cardiac rhythm management (CRM) devices to treat heart arrhythmias.

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