The FDA has granted 510(k) clearance to Biofourmis’ RhythmAnalytics, a cloud-based software product that uses deep learning to read and interpret cardiac arrhythmias.
According to a statement from the company and the FDA’s clearance letter, RhythmAnalytics collects single-lead ECG data from a range of FDA-cleared devices, and from these scan for more than 15 types of cardiac arrhythmias, including ventricular arrhythmia, ventricular ectopic beats and non-paced arrhythmias, such as atrial fibrillation.
As a software product, RhythmAnalytics is designed for integration into medical devices, as well as for electronically interfacing with other computer-based ECG systems. Its interpretations are not intended to act as the sole diagnosing factor, but to inform providers as they reach their own conclusions about the patient’s health.
“Comprehensive diagnosis of a patient’s cardiac health requires longer continuous monitoring and full characterization of multiple arrhythmias,” Kuldeep Singh Rajput, founder and CEO of Biofourmis, said in a statement. “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.”
Biofourmis wrote in its announcement that the software’s artificial intelligence models were trained using data from more than a million ECG recordings. The company also highlighted data from a recent preprint paper it submitted to the FDA with the application, which found RhythmAnalytics’ classifications kept pace, or exceeded, other models and clinician decisions.
WHAT’S THE IMPACT
Biofourmis said that it is planning to offer RhythmAnalytics as a software-as-a-service product to professional organizations monitoring patients’ cardiac health. By integrating with these customers’ existing systems, the company believes that its cloud-based API could provide additional accuracy and scalability of ECG analysis to these customers.
WHAT’S THE TREND
In November, Biofourmis announced a partnership with Brigham and Women’s Hospital that allowed the provider to better monitor patients recuperating in their homes. Still, it isn’t alone in the analysis software space — Cardiologs has long had an FDA clearance and CE Mark for its ECG clinical analysis algorithm, while Cardiogram’s software brings detection of atrial fibrillation, hypertension and other conditions to several popular wearables, to name just a few.
ON THE RECORD
“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,” Dr. Christopher J. McLeod, the clinical director for cardiovascular medicine at the Mayo Clinic, said in a statement. “Biofourmis has built an incredibly strong in-house data science and clinical capabilities and we look forward to working with them.”