Casana receives FDA clearance for smart toilet seat

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Casana has moved one step closer to bringing its product to market.

The health care technology firm recently said its Heart Seat has received clearance from the Food and Drug Administration for measuring heart rate and oxygen saturation.

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

Casana, which focuses on health care technologies that enable easy, integrated and consistent in-home health monitoring, has developed a smart toilet, a cuffless blood pressure monitor built into a toilet seat. Its first product aims to assist with the management and control of hypertension.

The company has partnered with researchers to conduct validation studies of additional clinical measurements. Casana plans to file for future indications this year, including systolic and diastolic blood pressure. It hopes to launch the Heart Seat by the end of the year. The seat is expected to help physicians track patient health between visits.

“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,” says George Bakris M.D., director of the Comprehensive Hypertension Center at the University of Chicago and a member of Casana’s scientific medical advisory board.

The Heart Seat was originally developed by Casana founder Nicholas Conn at Rochester Institute of Technology. McChord, an RIT alum, joined the business in 2020, after he grew Datto—a producer and seller of business software, cloud-based services and hardware—into a company reportedly valued at $1 billion. McChord left Datto in 2018.

So far, Casana has been successful at attracting investors. It has raised more than $46 million since its inception in 2018. After its Series B funding round last year—which raised $30 million—the company noted it would use the money to speed up the development and commercialization of the Heart Seat.

The COVID-19 pandemic has accelerated the demand for home health monitoring. In March, Casana shared results of clinical studies that validated the preference for monitoring vitals from home.

Among the nearly 500 subjects surveyed, 88 percent expressed their preference for monitoring their health from home rather than visiting a doctor’s office or medical facility, the company says. Seventy percent considered blood pressure as the most crucial health parameter that should be monitored.

Participants in two of the three studies either visited Casana’s Smart Integrated Technologies lab in Rochester or had a Heart Seat installed at home. Of these individuals, 87 percent preferred to use the passive toilet monitor over traditional blood pressure cuffs. Ninety-two percent trusted the transmission of their personal health data online.

“The acceptance and excitement around this product without it being readily available yet is unbelievable,” Conn, chief scientific officer at Casana, said at that time. “Knowing this toilet seat can help medical teams better manage chronic heart conditions one day makes every sleepless night worth it.”

A combination of factors could benefit Casana’s growth: a rapidly growing aging population, the pervasiveness of telehealth, rise in chronic diseases and an increased awareness of at-home monitoring. Grand View Research estimates that the global home health market will expand at a compound annual growth rate of nearly 8 percent from 2023 to 2030. It was valued at $362 billion last year. North America dominated the market and accounted for a revenue share of 42.7 percent that year, the report states.

Smriti Jacob is Rochester Beacon managing editor.The Beacon welcomes comments and letters from readers who adhere to our comment policy including use of their full, real name. Submissions to the Letters page should be sent to [email protected]

3 thoughts on “Casana receives FDA clearance for smart toilet seat

  1. There is no “outrage” in my response. I think you’re missing the point. There is nothing like face to face care. Although this may be a monitoring effort, it does chip away at less time in the office and more time spent with a computer. Let me cite you an example, a true story. This was told by a minister who took a patient to the E.R. The minister took that patient to the E.R. because she realized just by looking at the individual that she needed immediate care. The intake person spent 15 minutes asking questions and fingering the computer. She never looked up at the patient and connected the verbiage with the obvious state of the patient. After leaving the patient, still never meeting eyes, the patient collapsed and then it became all hands on deck. There needs to be a partnership between the technology and the compassionate care. Computers and the latest technology is only as good as the “in person” involvement and follow up. I do my share of writing and responding. There is no “outrage” on my part here. There is a regular “outrage” by me on the failure of the RCSD to educate our youth. You see, all kids have innate skills and or gifts. That innate skill and or gift need to be discovered in their K-12 journey. It aint getting done. It hasn’t been for decades. You have no idea on just how outraged I am.
    Semper Fi,

  2. How far we have drifted from compassionate, personal and quality health care. The face to face care has been replaced by the computer, AI and the like. And with all that “progress” we are still lagging behind in health care on the world stage. But we are raking in billions in profit related to health care. We are keeping Wallstreet healthy. In the end all you need is a computer and a health care toilet seat. Compassion has left the building and medical billing has become paramount in health care.

    • Your outrage is misplaced. This will be used for daily patient monitoring. I assume you don’t think people should have to go to their doctor’s office every day.

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