Developed by FaceHeart, FH Vitals SDK-RR has obtained FDA Clearance. This is the second 510(k) class II SaMD (Software as a Medical Device) FaceHeart received from the FDA. FaceHeart Vitals™ is a ...

Software allowing a digital video camera sensor to measure patients’ vital signs remotely has been approved as a Class IIa medical device in Europe in what is believed to be the first accreditation of ...

This year, jail officials started putting digital wristbands on inmates that measure vital signs. They can alert staff when a ...

Many of these devices currently sold over-the-counter do not have marketing authorization, the agency said in a notice.