Biofourmis issued the following announcement on Oct 3.
Biofourmis, a fast-growing global leader in digital therapeutics, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its machine-learning and artificial intelligence (AI)-powered Biovitals™ Analytics Engine as a medical device for ambulatory physiological monitoring.
This regulatory approval of the Biovitals™ Analytics Engine is part of FDA's growing recognition of machine-learning and AI in the Software as a Medical Device category.
"This milestone approval is foundational to the Biovitals™ ecosystem, which includes not only our most advanced solution, BiovitalsHF™ for heart failure—but also our range of solutions across therapeutic areas, such as pain, oncology, sleep disorders and others in development," said Kuldeep Singh Rajput, CEO and founder of Biofourmis. "Receiving this important regulatory approval will only accelerate the development and commercialization of these innovative digital therapeutic solutions."
This FDA approval is the second market authorization for Biofourmis, having earned the agency's approval in May 2019 for its Biovitals™ RhythmAnalytics™ platform, which is cloud-based software for automated interpretation of more than 15 types of cardiac arrhythmias. The newly cleared Analytics Engine is a much broader approval to process multiple physiology signals, as the technology serves as the foundation for all of Biofourmis' digital therapeutics product pipeline.
"The Biovitals™ Analytics Engine helps to fill a critical unmet medical need in heart failure care," said Raj Khandwalla, MD, MA, Assistant Professor at the Cedars-Sinai Smidt Heart Institute, Director of Cardiovascular Education at the Cedars-Sinai Care Foundation, and Biofourmis Clinical Advisory Board member. "Numerous studies consistently demonstrate that guideline-directed medical therapy is underutilized in patients with heart failure, which is likely the reason that historic decreases in morbidity and mortality have not only plateaued, but have unfortunately begun to increase. The Biovitals™ Analytics Engine within the context of the BiovitalsHF™ platform will likely lead to improved clinical outcomes."
An Important Tool in the Move to Value-Based Care
The Biovitals™ Analytics Engine receives physiologic data such as heart rate, respiratory rate and activity in near real-time from FDA-cleared sensors and leverages AI and machine learning to identify the correlation between multiple vital signs and the patient's daily activities, building an individualized biometric signature that is dynamically updated based on incoming data. The Biovitals™ Analytics Engine computes a time series Biovitals™ Index, which alerts providers to changes in patients' measured vital signs from their baseline—a precursor to decompensation that in some cases may be up to a few weeks before an event would have occurred without any intervention. This advance notice provides ample time for the clinician to take the necessary clinical steps to change the trajectory of the disease.
The Biovitals™ platform can potentially reduce hospital readmissions and decreases the need for emergency department (ED) visits. The real-world insights generated from the AI-powered Biovitals™ Analytics Engine also provide a foundation for pharmaceutical researchers and medical device manufacturers to develop more effective solutions—in less time and with smaller investments, thanks to more rapid and reliable clinical insights.
"As the healthcare industry transitions to risk-bearing, value-based care models, tools such as the Biovitals™ Analytics Engine are essential to efficiently and effectively monitor and detect changes in patients' health status before an adverse event leads to an ED visit or a hospital readmission," said Maulik Majmudar, MD, a cardiologist and Biofourmis Clinical Advisory Board member.
Rajput added: "Drug developers need real-world evidence to prove the efficacy of their drugs and value to payers. Research conducted using the Biovitals™ platform delivers that evidence in a much more cost-effective and timely process than traditional investigational methods."
Biovitals™ Analytics Engine Proven in Real-World Settings
Earning FDA 510(k) market clearance is based on a determination by FDA that the application contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use.
Biofourmis' application was based on clinical studies involving monitoring patients with complex chronic conditions such as heart failure, COPD and atrial fibrillation—at-home, in a real-world setting. In one study, the Biovitals™ Analytics Engine enabled earlier clinical intervention by predicting heart failure decompensation 12 days in advance of a heart failure-related hospitalization in a 73-year-old man—who had multiple comorbidities, including hypertension, COPD and diabetes—by combining multivariate physiology signals to generate actionable insight for clinicians to intervene. Another case was a 68-year-old man, also with multiple comorbidities. The intelligence generated from the Biovitals™ Analytics Engine alerted clinicians about a lack of medication regimen adherence, which resulted in an ED visit, but clinicians were able to avoid a hospital admission with changes to the patient's medication in the ED setting.
Biovitals™ Analytics Engine Use in Research Partnerships
The Biovitals™ Analytics Engine is also currently in use for research initiatives involving patients with heart failure. One research partnership is with the Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI). BiovitalsHF™, which is powered by the Biovitals™ Analytics Engine, is being used in this study of patients with heart failure to monitor functional capacity and quality of life to see if greater emphasis should be placed on these patient-centric measures in the drug approval process.
Biofourmis also has a partnership with Brigham and Women's Hospital, where the Biovitals™ Analytics Engine and Biovitals RhythmAnalytics™ are currently being used to continuously monitor for cardiac arrhythmias to manage patients at home as part of Brigham's Home Hospital Program. The patient numbers in the program have doubled on a month-on-month basis since the program began in November 2018.
"The Biovitals™ Analytics Engine can support numerous applications across all of healthcare, virtually anywhere where medical or health professionals need to gather physiologic data from patients in an ambulatory healthcare setting or at home," Rajput said. "The FDA clearance of the Biovitals™ Analytics Engine signals a change not only in the way healthcare is delivered and reimbursed, but also in how innovative pharmaceutical and device solutions are developed to improve outcomes for patients."
About Biofourmis
Biofourmis, a fast-growing global leader in digital therapeutics, discovers, develops and delivers clinically validated software-based therapeutics to provide better outcomes for patients, advanced tools for clinicians to deliver personalized care, technology to demonstrate the value of and potentially complement pharmacotherapy, and cost-effective solutions for payers. Biofourmis has built Biovitals™, a highly sophisticated personalized AI-powered health analytics platform that predicts clinical exacerbation in advance of a critical event, which is the backbone of their digital therapeutics product pipeline across multiple therapeutic areas, including heart failure, oncology, acute coronary syndrome, COPD and chronic pain.
Original source can be found here.
