Bodyport Cardiac Scale received FDA 510(k)

The Bodyport Cardiac Scale received U.S. Food & Drug Administration (FDA) 510(k) clearance. The 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 measure weight.

More than 6 million adults in the United States have heart failure, costing an estimated $30.7 billion annually and causing 12 million clinic visits and 1.2 million hospitalizations each year. More than 90% of these hospitalizations are due to hemodynamic changes resulting in fluid accumulation. Weight monitoring is 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 doesn’t provide enough warning to prevent hospitalization. Until now, patients and their medical teams haven’t 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 of 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 is designed to integrate into a patient’s daily life. Each time a person steps on the Cardiac Scale, advanced sensors and algorithms measure key hemodynamic biomarkers. The device 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.”

More than 10 hospitals and healthcare systems across the United States have participated in Bodyport’s clinical studies. The company plans to roll out the technology more broadly later this year.