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.
