FDA clears toilet seat-based heart monitor as company targets product launch by end of year

Casana, a Rochester, New York-based healthcare technology company, has received U.S. Food and Drug Administration (FDA) clearance for its Heart Seat toilet seat to be used for measuring a user’s heart rate and oxygen saturation levels.

The next step, Casana said in a prepared statement, is to pursue regulatory approval for evaluating systolic and diastolic blood pressure. The company is targeting an initial launch of the Heart Seat, a cloud-connected device that tracks a user’s cardiovascular health over time, by the end of 2023.

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

“As medicine moves from the physician’s office into the home, accurate home monitoring of medical parameters is increasingly important,” added George Bakris, MD, a professor of medicine at the University of Chicago and member of Casana’s scientific medical advisory board. “FDA approval is a critical validation step for the Heart Seat.”

Back in February 2021, Casana raised $14 million in Series A funding to help finance the development and marketing of the Heart Seat. The company was previously known as Heart Health Intelligence.  

Michael Walter
Michael Walter, Managing Editor

Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.

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