Tag: EU MDR
Route 92 gains EU and MDSAP certification for its neurovascular product...
Route 92 Medical announced today that it has obtained CE-mark approval under the EU Medical Device Regulation (MDR) 2017/745 for its innovative line of...
Endostream announces European MDR certification of Nautilus intrasaccular system
Endostream Medical has announced that it has officially received European Union (EU) Medical Device Regulation (MDR) certification for its Nautilus intrasaccular system—a novel device...
Avicenna.AI secures European MDR certification for AI medical imaging portfolio
Avicenna.AI has received Medical Device Regulation (MDR) certification for five of its algorithms from British Standards Institution (BSI) Medical Devices—a development that means the...
“The tables have turned”—US FDA regulation is becoming the envy of...
Discussions at this year’s European Society of Minimally Invasive Neurological Therapy (ESMINT) congress (4–6 September, Marseille, France) revealed the extent of the disparities between the...