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Is this “smart toilet” a medical device?

Smart Toilet Seat

The smart toilet seat includes three key sensors: an electrocardiogram to measure electrical activity of the heart; a photoplethysmogram to measure blood oxygen levels; and a ballistocardiogram to measure the mechanical force of the heart pumping blood.

Sensors in this battery-powered, cloud-connected toilet seat–based cardiovascular monitoring system successfully demonstrated cardiovascular monitoring of blood pressure, stroke volume, and blood oxygenation with the accuracy consistent with gold standard measurement. This system will be uniquely positioned to capture trend data in the home that has been previously unattainable, according to a study in the January issue of the journal JMIR mHealth and uHealth.

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“The medical device community was very quick to identify exactly how to classify the toilet. It depends upon the claims and the claims are in the instructions for use, the web site, and other marketing material. It was designed to give medically accurate heart health indications. If it does any diagnosis, it will be a medical device. If it only indicates that you should see a doctor, it will not be a medical device.

The blood Oxygen measurement, for example, could be a medical device all by itself, however there are pulse plethysmographs sold that are not medical devices, because they do not claim to diagnose or even give accurate blood Oxygen numbers.

The Apple watch and the AliveCor’s KardiaMobile make accurate ECG measurements. Both claim to detect atrial fibrillation, and both are classified as medical devices as result (the Apple Watch is not a medical devices, but the ECG app is).

The smart toilet was developed at the Rochester Institute of Technology for demonstration purposes. It was not used for diagnosis, and it does not have any claims, therefore it is not a medical devices. If the creators put it on the market to sell, I would expect they would want to make claims similar to Apple and AliveCor, in which case it would be a medical device.” – Walter Maclay

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