FDA clears Biofourmis RhythmAnalytics arrhythmia AI platform

Biofourmis (Singapore) has received FDA clearance for its RhythmAnalytics platform.

The cloud-based software offers an automated interpretation of cardiac arrhythmias. It uses enhanced deep learning to detect over 15 types of cardiac arrhythmia with beat-by-beat morphology computation that includes ventricular arrhythmias, ventricular ectopic beats and non-paced arrhythmia.

The artificial intelligence models were trained using more than a million ECG recordings using a number of FDA-cleared ECG monitoring wearables. ECG recordings were collected from patients who have a history of cardiac arrhythmia using ambulatory ECG monitoring devices like the ePatch extended holder monitor from BioTelemetry, which was the same cardiac monitor used in Apple’s heart study.

“Comprehensive diagnosis of a patient’s cardiac health requires longer continuous monitoring and full characterization of multiple arrhythmias. We are on a mission of predicting and preventing serious medical events using software-based therapeutic intervention and RhythmAnalytics is an integral part of our digital therapeutics platform that would enable prescription of the right dose to the right patient at the right time,” founder and CEO of Biofourmis Kuldeep Singh Rajput said in a press release. “We are excited about this milestone and look forward to using RhythmAnalytics to enable clinicians to detect a wide range of cardiac arrhythmias and provide appropriate treatment and therapy.”

The company plans to offer RhythmAnalytics as a software-as-a-service to cardiac monitoring organizations to improve the accuracy and scalability of ECG analysis.

“Diagnostic interpretation of ambulatory ECGs are not only resource intensive but can also carry high rates of diagnostic errors,” Dr. Maulik Majmudar, a cardiologist and member of Biofourmis’s clinical advisory board, said. “Given the interest in, and availability of, OTC consumer-focused ECG acquisition devices on the market today, there is a growing need for rapid, automated, and highly accurate interpretation of single-lead ECGs for a wide array of cardiac rhythm disorders. The FDA-cleared RhythmAnalytics platform directly addresses that need.”

Biofourmis is currently working with Mayo Clinic and Brigham and Women’s Hospital and also has partnerships with a number of global pharmaceutical companies for its digital therapeutics platform.

“The Biofourmis RhythmAnalytics platform ushers in a new era of computer-aided ECG interpretation – harnessing refined deep-learning techniques that I strongly feel will revolutionize care by improving throughput and reducing costs while maintaining accuracy. Biofourmis has built an incredibly strong in-house data science and clinical capabilities and we look forward to working with them,” said Dr. Christopher McLeod, clinical director for cardiovascular medicine at Mayo Clinic.

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