Regulations
Has your technology gone through IRB approved clinical trials?

Yes, FH Vitals™ technology has gone through several IRB-approved clinical trials in six hospitals across multiple departments in Taiwan. The extensive clinical data collected during these trials have enabled FH Vitals™ to integrate doctors’ knowledge into our algorithm calibration measuring at medical-grade accuracy.

Can FH Vitals™ be used as a medical equipment?

FH Vitals™ is currently under application for FDA Class II clearance, which is expected to be approved in 2022.

Is it GDPR and HIPPA compliant?

FH Vitals™ merely displays the data and performs all its calculations on the edge, which alleviates any data privacy and security concerns.

What patents do FaceHeart own?

As of now, we have over 80 patents either being granted or under application in Taiwan, the U.S., China, and Europe.

FH Vitals™ technology adds
value to our customers' products.