SAN FRANCISCO--(BUSINESS WIRE)--Bodyport, a digital therapeutics company on a mission to address complex chronic conditions, announced today that its noninvasive biomarker platform, the Bodyport Cardiac Scale™ received U.S. Food & Drug Administration (FDA) 510(k) clearance. This innovative solution enables people with fluid management conditions, such as heart failure and kidney disease, to noninvasively assess measures of heart function and fluid status in the same step they take to measure their weight.
More than 6 million adults in the United States have heart failure, costing the U.S. an estimated $30.7 billion annually and causing 12 million clinic visits and 1.2 million hospitalizations each year.i More than 90% of these hospitalizations are due to hemodynamic changes resulting in fluid accumulation.ii Weight monitoring is currently the noninvasive standard of care for detecting fluid changes in patients with heart failure. However, weight gain is a late sign of worsening status, and typically does not provide enough advance warning to deliver an effective intervention that can prevent a hospitalization. Until now, patients and their medical teams have not had simple, noninvasive devices to measure earlier signs of worsening fluid status in the 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," said John Lipman, CEO, Bodyport. "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."
The Cardiac Scale was designed to seamlessly integrate into a patient's daily life, leveraging a familiar form factor and existing habit of daily self-weighing. Each time a person steps on the Cardiac Scale, advanced sensors and algorithms measure key hemodynamic biomarkers. The device then sends these data over a cellular network to care teams, providing a window into patient status that enables efficient and effective care.
"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."