REGULATORY NEWS

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

FDA grants expanded indication for Linear Health Sciences’ Orchid Safety Release Valve

Linear Health Sciences, a medical device company that has developed a proprietary, breakaway safety valve platform, has announced that it received an expanded indication for its Orchid Safety Release Valve (SRV) from the FDA. Read more

Penumbra receives CE Mark for Lightning Flash 2.0 and Lightning Bolt 7

Penumbra, Inc has announced it has secured CE Mark in Europe for the latest computer assisted vacuum thrombectomy (CAVT) technologies – Lightning Flash 2.0 and Lightning Bolt 7. Read more

Medtronic earns FDA approval for expanded MRI labelling

Medtronic has received U.S. Food and Drug Administration (FDA) approval of its expanded magnetic resonance imaging (MRI) labeling for Medtronic Percept PC and Percept RC, as well as Medtronic Activa PC, RC and SC. Read more

Vitestro achieves CE marking for autonomous blood drawing device

Vitestro has announced that its automated blood drawing device has received CE marking. This acknowledges that the device meets the requirements of the European Medical Device Regulation (MDR) and is now approved for commercial use across the EU. Read more

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