The U.S. medical devices regulator, the Food & Drug Administration, has cleared it as a Class IIA (medium risk) medical device. The startup’s debut sensing gadget is called Keikku, which means ...

Oxehealth Vital Signs – which has been approved as a class IIa medical device in Europe since 2018 – operates as part of the company's Oxevision platform, which consists of an optical sensor i ...

Tracey Technologies’ iTrace uses ray tracing technology to obtain precise measurements of the eye’s internal and external ...

For healthcare firms involved in the spaces of software-as-a-medical-device (SaMD), or digital ... and your product is Class IIa or higher, you're definitely under the AI act.

Newel Health has been granted EU medical device certification for its virtual reality-based digital therapeutic (DTx) for ...

Trace - True Ray Tracing Aberrometer and Topographer Tracey Technologies announced that the company has successfully achieved certificatio ...