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# Biotronik Injectable Cardiac Monitor Cleared
- URL: https://www.fdaweb.com/biotronik-injectable-cardiac-monitor-cleared/
- Published: 2019-07-10T12:00:00.000Z
- Updated: 2026-09-15T01:36:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144503

FDA has cleared a Biotronik 510(k) for the Biomonitor III injectable cardiac monitor. The device is designed to document suspected arrhythmia or unexplained syncope with increased clarity, enabling fast diagnosis and appropriate treatment, the company says. Biomonitor III is 60% smaller than its predecessor and comes “pre-loaded in an injection tool with no assembly required, significantly simplifying the insertion process,” it says. “Biomonitor III will also feature a patient app to support patient-provider engagement. The app reports system diagnostics and offers a method for patients to annotate symptoms with automatic synchronization to Biotronik Home Monitoring.”