Biomonitor IV ICM receives CE mark approval

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Biotronik has announced the CE mark approval and first European implant of its latest insertable cardiac monitor (ICM)—Biomonitor IV.

The device features artificial intelligence (AI) for false positive reduction, and according to Biotronik is the only ICM on the market with premature ventricular and atrial contraction (PVC and PAC) discrimination capabilities.

False positive detections may take clinicians a considerable amount of time to review. Biomonitor IV features SmartECG, an intelligent system powered by artificial intelligence (AI) and advanced algorithms to reduce false positive detections for atrial fibrillation (AF), bradycardia, tachycardia, and pause.

SmartECG reduces 86% of false detections across all major arrhythmias while keeping 98% of the clinically relevant episodes, Biotronik says in a press release.

“Biomonitor IV enables me to distinguish between PVC and PACs and clearly report burden over time. The new AI-based algorithm and the Quick View report offer me easy and efficient review, dedicate more time to my patients and their personalised treatment”, said Gerardo Nigro (“L Vanvitelli” University of Naples, Naples, Italy), who implanted the first Biomonitor IV in Europe.

“AI and connected cardiac solutions have the potential to revolutionise healthcare. Our latest innovation, Biomonitor IV, will propel the field of cardiac monitoring in this new direction. Biotronik was the first company to introduce remote care of cardiac rhythm devices over 20 years ago. Today, we will lead a new direction in intelligent systems that streamlines clinicians’ workflow and turns an industry overwhelmed with data into personalised and actionable care”, says Andreas Hecker, president CRM/EP at Biotronik.


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