The Food and Drug Administration (FDA) has cleared the Bodyport Cardiac Scale™ for noninvasive monitoring and management of patients 21 years and older (weighing less than 180kg) with fluid management related health conditions.
The Bodyport Cardiac Scale is intended to be used to measure and track body weight, peripheral impedance, pulse rate, and center of pressure; it can be used in the home or clinical environment. The device is comprised of a physical platform on which the user stands with bare feet.
The measurement starts automatically when the user steps on the scale. Data collected by the Bodyport Cardiac Scale is automatically transmitted via cellular communication to the Bodyport cloud where it can be accessed by the care team.
The FDA clearance of the Bodyport Cardiac Scale was supported by an analysis of clinical data that demonstrated both the accuracy of the pulse rate measurement, as well as the utility of peripheral impedance in monitoring patients with fluid management conditions. The study included heart failure patients, as the fluid management group, and healthy individuals, as the control group.
“During our clinical study (ClinicalTrials.gov Identifier: NCT04975633) 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,” said Dr Michael Fong, Co-Founder of the Advanced Heart Failure and Cardiomyopathy Clinic, Keck Medical Center of USC. “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.”
Bodyport plans to make the device available broadly later this year.
- Bodyport receives FDA Clearance for the Bodyport Cardiac Scale™. News release. Bodyport. Accessed August 9, 2022. https://www.businesswire.com/news/home/20220809005479/en/Bodyport-Receives-FDA-Clearance-for-the-Bodyport-Cardiac-Scale%E2%84%A2
- Solution. Bodyport. Accessed August 9, 2022. https://www.bodyport.com/#solution
- US Food and Drug Administration. Bodyport Cardiac Scale 510(k) Summary. Food and Drug Administration. Accessed August 9, 2022. https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211585.pdf