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The SaMD manufacturer is the person or entity (company or corporation) legally responsible for the design and/or manufacturing of a SaMD....

“Software as a Medical Device,” or SaMD, refers to a software product that is intended for medical purposes but is independent from...

A medical device is defined as any “instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,...

Eric Topol on the wireless future of medicine In this TEDMED Talk, Eric Topol, MD, discusses the bright future of wireless and remote...

In a previous insight, we discussed how to evaluate if your real-world evidence (RWE) is good enough. In this one, let’s take a different...

An overview for digital health entrepreneurs Digital innovation will transform clinical trials. It’s inevitable…still, innovators need to...