Biofourmis Receives FDA Clearance for RhythmAnalytics, an AI-Powered Cloud-Based Platform for Accurate Arrhythmia Detection

VCBeat (WeChat ID: vcbeAt) has learned that RhythmAnalytics, a cloud-based software developed by digital health company Biofourmis, has recently received FDA approval for the detection of arrhythmias. Leveraging deep learning models, the software can detect and analyze more than 15 types of arrhythmic conditions, encompassing all non-rhythmic arrhythmia disorders such as ventricular arrhythmias, premature ventricular contractions, and atrial fibrillation.

Biofourmis, founded in 2015 and headquartered in Singapore, is a rapidly growing digital health startup. The company is dedicated to leveraging artificial intelligence to analyze medical data collected from patients—sourced from wearable devices, hospital databases, personal laboratory reports, and more—thereby delivering personalized healthcare services, assisting physicians in diagnosis and treatment, and enhancing patient safety.

Since its inception, Biofourmis has secured four rounds of funding. In August 2016, the company raised $1 million in seed funding led by SpesNet and Eden Strategy; in December 2017, it raised $5 million in Series A funding from NSI Ventures and Aviva Ventures.

It is understood that traditional arrhythmia detection methods are prone to false positives, with a misdiagnosis rate approaching 50%, which significantly increases healthcare costs. RhythmAnalytics has collected one million electrocardiogram (ECG) records from wearable devices and medical equipment with ECG monitoring capabilities, establishing an advanced deep learning model that can help cardiologists accurately detect arrhythmias.

Kuldeep Singh Rajput, Founder and CEO of Biofourmis, stated, “Comprehensive diagnosis of patients’ cardiac conditions typically requires prolonged continuous monitoring. Our mission is to leverage cloud-based software to rapidly detect various types of arrhythmias and provide personalized treatment plans for patients.”

Dr. Maulik Majmudar, a cardiologist and member of Biofourmis’ Clinical Advisory Board, stated, “Traditional methods for analyzing Holter monitor data not only consume substantial medical resources but also result in high rates of misdiagnosis. Physicians and caregivers urgently need fast, automated, and highly accurate software or devices to diagnose arrhythmias, and RhythmAnalytics meets this need.”

Currently, Biofourmis is collaborating with leading hospitals such as Mayo Clinic and Brigham and Women’s Hospital. These institutions are adopting RhythmAnalytics to remotely monitor patients with arrhythmias, enabling physicians to easily manage patients at home. Meanwhile, the company has established partnerships with five globally leading pharmaceutical companies to jointly develop its digital therapeutic platform, of which RhythmAnalytics is a key component.

Christopher J. McLeod, Clinical Director of Cardiovascular Medicine at Mayo Clinic, stated, “RhythmAnalytics ushers in an era of computer-assisted ECG analysis. By leveraging advanced deep learning technologies, the software enhances the accuracy of arrhythmia detection, reduces healthcare costs, and lowers readmission rates. This will transform hospital care models.”

(Compiled by Jiao Yanli)