REGULATORY NEWS

Medtronic receives CE Mark for Endoflip system

Medtronic plc, a global leader in healthcare technology, has announced it has received CE Mark approval for its next generation Endoflip 300 system to measure pressure and dimensions in the oesophagus and pylorus in adults. Read more

Urgent revision of European medical device regulations is ‘positive, timely step’, says expert

The European Parliament has adopted a resolution calling for swift revision of both the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) in response to “the most pressing challenges and bottlenecks”. Read more

FDA grants De Novo authorisation for Distalmotion's Dexter Surgical Robot

Distalmotion has been granted De Novo approval by the U.S. Food and Drug Administration (FDA) to market the Dexter Surgical Robot for adult inguinal hernia repair. Read more

Yourgene Health Cystic Fibrosis Base Assay receives IVDR accreditation

Yourgene Health has announced that it has received accreditation under the new EU requirements of the in vitro diagnostic regulation (IVDR) for the Yourgene Cystic Fibrosis Base Assay. Read more

OrganOx metra system approved for liver transplantation in Canada

OrganOx Ltd, a leading organ medical technology company, has announced that Health Canada has approved the OrganOx metra System for use during liver transplantation. Read more

Elucid receives FDA clearance for PlaqueIQ image analysis software

Elucid has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its PlaqueIQ imaging analysis software to help physicians diagnose cardiovascular disease (CVD). Read more

Revolutionising High-End Medical Imaging with Advantech SQR-SD5N Integration