Tag: medical devices
“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...
Early Feasibility Study programme has potential to advance US neurovascular space
At a time when many of Europe’s medical technology markets are effectively going backwards due to complications created by the EU Medical Device Regulation...
European Society for Brain Stimulation “strongly opposes” reclassification of non-invasive devices
The European Society for Brain Stimulation (ESBS) has said it “strongly opposes” the European Union’s (EU) recent decision to reclassify non-invasive brain stimulation (NIBS)...
EU ministers approve changes to MDR transition timetable
The European Union’s (EU) Council of Ministers has today adopted a resolution to extend the deadline for the certification of medical devices under the...
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 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...
