Remote monitoring has become an essential component of virtual wards and community-based care. As adoption accelerates, understanding medical-device classification is not a legal technicality, but a ...

It is a scenario nearly as old as the security industry itself: An alarm is tripped, it is routed to a central station, which eventually routes it to law enforcement, and then police, fire or EMS ...

The various GMP guidelines and International ISO standards around GMP cleanrooms are complex and often appear to give conflicting advice, leading to confusion and sometimes incorrect interpretation.

The US Food and Drug Administration (FDA) has granted de novo classification to Biolinq Shine, a wearable biosensor that would be the first needle-free continuous glucose monitoring (CGM) device to ...

Fifth Eye, a Michigan-based real-time clinical analytics company, announced today that the Food and Drug Administration has granted De Novo classification for its Analytic for Hemodynamic Instability ...