Lasix® ONYU[1] Achieves CE Marking under EU Medical Device Regulation, Reaching a Critical Milestone Toward International Market Authorization; European Medicines Agency ...

SQ Innovation, developer of Lasix® ONYU, today announced two important regulatory milestones in its international expansion strategy: the receipt of a CE marking certificate for the Lasix ONYU device, ...
RAPS

EMA pilot aims to advise on orphan device development

Medical device manufacturers and notified bodies in the European Union may qualify for free advice on orphan medical devices under a new pilot program launched by the European Medicines Agency (EMA).
RAPS

EMA launches early scientific advice program for high-risk medical devices

The European Medicines Agency (EMA) and the European Commission have developed a standard procedure for certain high-risk medical device manufacturers to ask for scientific advice from a panel of ...
Hosted on MSN

Carthera’s ultrasound system earns EMA endorsement as an orphan medical device

Carthera has received an orphan medical device status endorsement for its SonoCloud ultrasound system for treating brain disorders under a new pilot programme by the European Medicines Agency (EMA).
BioWorld

EMA launches pilot for breakthrough medical devices in the EU

The European Medicines Agency (EMA) has launched a pilot program to fast track breakthrough medical devices in the EU and get ...