FDA OKs Bodyport’s Cardiac Scale, a Noninvasive Biomarker Platform

Digital therapeutics firm Bodyport has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Bodyport Cardiac Scale, a noninvasive biomarker platform.
 
The scale lets those with fluid management conditions like heart failure and kidney disease noninvasively evaluate measures of heart function and fluid status in the same step they take to measure their weight.
 
Until the Cardiac Scale, patients and medical teams haven’t had simple, noninvasive devices to measure earlier signs of fluid status at home.
 
“As we bring this easy-to-use, noninvasive solution to market, we look to dramatically improve how patients with heart failure are currently managed. Patients with heart failure and their caregivers have few options outside of a standard weight scale or a costly and invasive implant,” John Lipman, CEO of Bodyport told the press. “The comprehensive health assessment from the Cardiac Scale provides metric-driven, personalized care to those in need. This FDA 510(k) clearance is an important milestone, allowing us to expand access in support of our goal to keep people with fluid management conditions healthier and out of the hospital.”
 
Every time a person steps on the Cardiac Scale, advanced sensors and algorithms measure critical hemodynamic biomarkers. The device then sends data over a cell network to the care teams for a look into patient status.
 
“Successful heart failure management requires frequent access to meaningful information, such as fluid status, that is sometimes difficult to gauge by both providers and our patients,” said Dr. Michael Fong, co-founder of the Advanced Heart Failure and Cardiomyopathy Clinic, Keck Medical Center of USC. “During our clinical study using the Bodyport Cardiac Scale, we found patients more engaged, and our clinical team better empowered to make timely, individualized treatment adjustments to get ahead of changes in a patient’s condition before they worsen. We are excited about what we saw in the study; the interventions this has led to for some of our patients, and the potential impact it will have for our entire heart disease population.”
 
“The Bodyport Cardiac Scale is a significant step forward in the standard of care for the remote management of patients with cardiorenal conditions. By providing a longitudinal view of fluid status, care teams can more effectively manage their patients through simple, optimized lifestyle and medication adjustments,” said Corey Centen, co-founder, president, and CTO of Bodyport.
 
Over 10 leading U.S. hospitals and healthcare systems were involved in Bodyport’s clinical studies. The company aims more broad rollout of the technology later this year.