FDA Clears Bodyport Cardiac Fluid Scale

FDA has cleared a Bodyport 510(k) for its biomarker platform Bodyport Cardiac Scale that is intended to assess measures of heart function and fluid status for people with fluid management conditions, such as heart failure and kidney disease. “Weight monitoring is currently the noninvasive standard of care for detecting fluid changes in patients with heart failure,” the company says. “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, Bodyport says. Each time a person steps on the Cardiac Scale, advanced sensors and algorithms measure key hemodynamic biomarkers, according to the company. The scale then sends the data over a cellular network for care teams to evaluate.