Digital therapeutics firm Bodyport has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Bodyport Cardiac Scale, a non-invasive biomarker platform.
The new easy-to-use cardiac scale allows individuals with fluid management conditions such as kidney disease and heart failure to noninvasively monitor heart function and fluid status in a single step at home.
Using a familiar factor and existing daily self-weighing habit, the device has been designed to integrate into the daily life of a patient seamlessly.
Bodyport Cardiac Scale’s advanced sensors and proprietary algorithms noninvasively measure the important hemodynamic biomarkers when a person steps on it.
The solution detects signals through a person’s feet and sends the data through a cellular network so that it reaches the clinical care team in seconds.
Bodyport CEO John Lipman said: “As we bring this easy-to-use, non-invasive solution to market, we look to dramatically improve how patients with heart failure are currently managed.
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“Patients with heart failure and their caregivers have few options outside of a standard weight scale or a costly and invasive implant. The comprehensive health assessment from the Cardiac Scale provides metric-driven, personalised 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.”
According to the company, more than six million adults have heart failure in the US, which causes 12 million clinic visits and 1.2 million hospitalisations every year.
Hemodynamic changes that result in fluid accumulation are the reason for more than 90% of these hospitalisations.