FDA clears smart toilet seat for monitoring heart health

The Food and Drug Administration has cleared the Heart Seat-a smart toilet seat that measures heart rate and oxygen saturation.

The clearance marks a significant milestone for Casana in its pursuit to enable effortless home health monitoring.

Alongside Heart Rate and Oxygen Saturation (SpO2), Casana has partnered with researchers to conduct validation studies of additional clinical measurements. The company plans to file future indications this year, including Systolic and Diastolic Blood Pressure (BP), with the target of an initial product market launch by the end of 2023.

"This clearance is a critical step on our journey to commercialize the Heart Seat,” said Casana CEO, Austin McChord. “This brings us one step closer to helping patients and healthcare providers across the US manage their health at home."

Casana is unlocking a new category in healthcare technologies that enables effortless, integrated, and consistent in-home health monitoring. According to a report by Grand View Research, the global home healthcare market size was valued at USD 305.7 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 7.9% from 2021 to 2028.

Dr. George Bakris, Director of the Comprehensive Hypertension Center at UChicago and member of Casana’s Scientific Medical Advisory Board, commented, "As medicine moves from the physician’s office into the home, accurate home monitoring of medical parameters is increasingly important. FDA approval is a critical validation step for the Heart Seat."

The Heart Seat is a replacement for a standard toilet seat that is indicated for use in a home environment. The Heart Seat is intended to be used for measuring, displaying, reviewing and storing non-invasive functional oxygen saturation of arterial hemoglobin (SpO2) and heart rate (HR) in adults of at least 22 years of age with weight ranging from 90 to 350 pounds. Data from the Heart Seat are collected whenever the seat is used and are automatically uploaded to the Casana Cloud where they can be viewed by the healthcare provider. The Heart Seat is not intended for continuous monitoring.