Tag: medical devices

Swiss parliament votes to accept US FDA-approved medical devices

The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food and Drug Administration (FDA) marketing authorisation in Switzerland. A motion...
vesalio

Vesalio announces EU MDR certification of neurovascular product lines

Vesalio has announced EU Medical Device Regulation (MDR) certification of its product lines—achieving this “significantly ahead” of its May 2023 deadline, according to a...

MIVI Neuroscience names Waleed Brinjikji as new medical director

Next-generation neurointerventional medical device innovator MIVI Neuroscience has announced that Waleed Brinjikji (Mayo Clinic, Rochester, USA) has joined the company as its medical director. “The...

FDA issues two final guidances for including patient perspectives in medical...

The US Food and Drug Administration (FDA) has issued two final guidances providing recommendations for including patient perspectives in medical device clinical studies.   As...