The Apple Watch required FDA clearance (though this was only the 4 with the ECG feature). Since the EU has required approval even for some phone apps for fertility cycles I think a fitness watch that says it provides clinically accurate blood pressure readings may fall onto some radars.
I don't think the FDA, and especially EU regulators, look upon consumer devices that replicate medical functions lightly, since these can burden healthcare professionals and result in misdiagnosis/self-diagnosis.
This should be an interesting read (not entirely related but somewhat similar): https://www.fda.gov/inspections-compliance-enforcement-and-c...
The Apple Watch required FDA clearance (though this was only the 4 with the ECG feature). Since the EU has required approval even for some phone apps for fertility cycles I think a fitness watch that says it provides clinically accurate blood pressure readings may fall onto some radars.
I don't think the FDA, and especially EU regulators, look upon consumer devices that replicate medical functions lightly, since these can burden healthcare professionals and result in misdiagnosis/self-diagnosis.