Casana, maker of a health monitoring smart toilet seat, announced this week it had received its first FDA 510(k) clearance.
The startup’s Heart Seat received the agency green light for monitoring heart rate and oxygen saturation in adults at least 22 years and older who weigh 90 to 350 pounds. Casana said the battery-powered seat can run for several years without recharging, sending health data to providers and notifying them when parameters are outside of a set threshold.
The company plans to file with the FDA for additional monitoring capabilities, including blood pressure tracking, and to launch the product before the close of the year.
“This clearance is a critical step on our journey to commercialize the Heart Seat,” Casana CEO Austin McChord said in a statement. “This brings us one step closer to helping patients and healthcare providers across the U.S. manage their health at home.”
THE LARGER TREND
Casana, formerly named Heart Health Intelligence, was founded in 2018 in partnership with the University of Rochester Medical Center. Founder and chief scientific officer Nicholas Conn first developed the Heart Seat while completing his doctorate at the Rochester Institute of Technology.
Early last year, the company raised a $30 million Series B round, boosting its total funding pot to $46 million.
Remote patient monitoring is a growing space in digital health, with a number of startups and established health tech players developing monitoring systems. A 2022 study published in Health Affairs found billing for remote patient monitoring increased more than fourfold at the beginning of the COVID-19 pandemic. However, that expansion was driven by a small number of primary care providers.
Another company that has moved into remote monitoring is connected tech company Withings. Early this year, it announced U-Scan, a device that can be placed inside a toilet bowl to monitor an individual’s health using urine analysis.