Biofourmis's software to detect irregular heartbeat gets US FDA clearance

Biofourmis's software to detect irregular heartbeat gets US FDA clearance

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3 -min read
Listen to this article

BIOFOURMIS, a Singapore-based health-tech startup, has received clearance from the US Food and Drug Association (FDA) for its cloud-based software, RhythmAnalytics, which aids healthcare professionals in detecting cardiac arrhythmia, or irregular heartbeart.

The software uses deep learning to analyse and interpret data collected from FDA-approved electrocardiography (ECG) monitoring devices from patients with a history of cardiac arrhythmia.

RhythmAnalytics can detect more than 15 types of cardiac arrhythmias and will be an integral part of Biofourmis's Digital Therapeutics platform, the startup's proprietary algorithm-based platform for therapeutic decision-making.

The software can either be integrated as a cloud-based Application Programming Interface into existing cardiac monitoring solutions, or directly integrated into a medical device or wearable sensor. This results in more accurate analyses and increases the scalability of the solution, reducing the rate or misinterpretation and inappropriate patient management. 

Maulik Majmudar, cardiologist and a member of Biofourmis’s clinical advisory board said: “Diagnostic interpretation of ambulatory ECGs are not only resource intensive, but can also carry high rates of diagnostic errors. Given the interest in, and availability of, (over-the-counter) 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.”

The health-tech firm plans to offer RhythmAnalytics as a Software-as-a-Service (SaaS) to cardiac monitoring organisations to improve accuracy and scalability of their ECG analysis, in turn improving throughput and efficiencies in cardiac monitoring centres.

In November 2018, Biofourmis announced a partnership with Brigham and Women's Hospital, offering RhythmAnalytics as an investigational device exemption. Currently, the software is being used to continuously monitor for cardiac arrhythmia and manage patients at home, through the Brigham's Hospital Program.

Kuldeep Singh Rajput, founder and CEO of Biofourmis said: “Comprehensive diagnosis of a patient’s cardiac health requires longer continuous monitoring and full characterisation 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."

Biofourmis was founded in Singapore in November 2015 and now has over 40 employees in Singapore and Boston. Mr Rajput was recently listed on Forbes 30 under 30 list in Asia.