The Food and Drug Administration (FDA) has cleared Casana’s Heart Seat™ toilet seat for use in a home environment to measure heart rate and oxygen saturation (SpO2) in adults at least 22 years of age weighing 90 to 350 pounds.
Using sensors embedded in the toilet seat, the device is able to measure these vital signs and send the data automatically to the Casana Cloud. From there, a designated health care provider is able to view the data generated from the 3 sensors: a ballistocardiogram (which measures the mechanical activity of the heart), an electrocardiogram (which measures the electrical activity of the heart), and a photoplethysmogram (which detects blood volume changes).
Results from a study that evaluated the accuracy of the seat showed that it was able to consistently measure blood pressure, stroke volume, and blood oxygenation when compared with a hospital-grade vital signs monitor. The Company plans to conduct more testing and will file an application with the FDA to include additional clinical measurements, such as blood pressure monitoring, this year.
The Heart Seat is anticipated to launch by the end of 2023.
- Casana receives FDA clearance for heart health smart toilet seat. News release. Casana. May 1, 2023. https://www.globenewswire.com/news-release/2023/05/01/2658334/0/en/Casana-Receives-FDA-Clearance-for-Heart-Health-Smart-Toilet-Seat.html.
- Conn NJ, Schwarz KQ, Borkholder DA. In-home cardiovascular monitoring system for heart failure: Comparative study. JMIR Mhealth Uhealth 2019;7(1):e12419 doi:10.2196/12419