Biofourmis' RhythmAnalyticstm Platform Receives FDA Clearance For AI-based Automated Interpretation Of Cardiac Arrhythmias
A cloud-based, deep learning software platform can aid healthcare professionals in detecting over 15 types of cardiac arrhythmias using ambulatory ECG monitoring recordings.
BOSTON - April 30, 2019 - PRLog -- ● Biofourmis receives FDA clearance for its cloud-based SaaS platform, RhythmAnalyticsTM
● Biofourmis currently works with leading hospitals like Mayo Clinic, Brigham and Women's Hospital and has also secured partnerships with over 5 leading global pharmaceutical companies for its Digital Therapeutics platform.
● The AI-models were trained using over a million ECG recordings collected using various FDA-cleared ECG monitoring wearables.
Biofourmis announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its RhythmAnalyticsTMplatform, a cloud-based software for automated interpretation of cardiac arrhythmias. It uses an enhanced deep-learning technique to detect over 15 types of cardiac arrhythmias along with beat-by-beat morphology computation which include ventricular arrhythmias, ventricular ectopic beats and all non-paced arrhythmias including Atrial Fibrillation (AFib).
Biofourmis team has trained a densely connected convolutional neural network using more than a million single-lead ECG recordings collected from patients with a history of cardiac arrhythmias using a variety of ambulatory ECG monitoring devices, one of which is the ePatch extended holter monitor from BioTelemetry Inc., which was also used as a cardiac monitoring device in the Apple Heart Study.
In a recent arXivpaper, the company demonstrated cardiologist-
"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 RhythmAnalyticsTM 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," said Kuldeep Singh Rajput, Founder and Chief Executive Officer of Biofourmis. We are excited about this milestone and look forward to using RhythmAnalyticsTMto enable clinicians to detect a wide range of cardiac arrhythmias and provide appropriate treatment and therapy."
Traditional approaches to cardiac rhythm classification are prone to large false positives, leading to misdiagnosis, that significantly increases the healthcare utilization cost. Studies1have also shown that the computerized arrhythmia interpretation error rates approach 50%.RhythmAnalyticsTMsupports analysis of electrocardiograms (ECG) captured from any FDA cleared devices or wearable sensors such as Holter monitors, event recorders, or other similar devices. It can either be integrated as a cloud-based API into existing cardiac monitoring solutions or directly integrated into a medical device or wearable sensor, which significantly improves the accuracy and scalability of ECG analysis, reducing the rate or misinterpretation and inappropriate patient management.
Biofourmis plans to offer RhythmAnalyticsTMcloud-based API as Software-as-
Biofourmis also announced its partnership with Brigham and Women's Hospital in November 2018, where RhythmAnalyticsTMis currently being used to continuously monitor for cardiac arrhythmias and manage patients at home, at Brigham's Home Hospital Program. The patient numbers have doubled on a month-on-month basis.
"The Biofourmis RhythmAnalyticsTMplatform 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 J. McLeod, Clinical Director for Cardiovascular Medicine at Mayo Clinic.
Biofourmis is a fast-growing global start-up founded in Singapore that is on a mission of augmenting personalized care and therapies with Digital Therapeutics for better management of patients with complex chronic conditions. They discover, develop and deliver clinically-validated software-based therapeutics to provide better outcomes for patients, advanced tools for clinicians to deliver personalized care, and cost-effective solutions for payers. Biofourmis has built Biovitals™, a highly sophisticated personalized AI-empowered health analytics platform that predicts clinical exacerbation days in advance before a critical event, which is the backbone of their Digital Therapeutics product pipeline across therapeutic areas including heart failure, acute coronary syndrome, COPD, and chronic pain. For more information visit: www.biofourmis.com