Regulatory Approvals

Investigational EVAS System Designed for Patients with Complex Abdominal Aortic Aneurysm Endologix LLC, a leader in the treatment of vascular disease, today announced the company’s...

AliveCor has today announced the receipt of 510(k) clearance from the US Food and Drug Administration (FDA) for healthcare professionals to use the KardiaMobile...

New Savanna® platform can analyze up to 12 pathogens, plus controls, from a single sample Savanna® RVP4 Assay targets influenza A+B, RSV and COVID-19 Quidel Corporation...

Natural Cycles, the first FDA cleared birth control app, has received new FDA clearance to revise its labelling and expand the types of third-party...

Siemens Healthineers Announces FDA Clearance of MAGNETOM Free.Max 80 cm MR Scanner Company’s smallest, most lightweight scanner uses less than 1 liter of helium and...

NuVasive has revealed that its Pulse platform received CE Mark approval for its latest design update and clinical evaluations are now underway in multiple...

- MicromateTM, the world's smallest head-to-toe medical robot, was FDA-cleared, making way for the European company to start building its US presence; - The robot,...

With a recent influx of more than $70 million in a series C financing and, now, a shiny new CE mark for its stroke-spotting...

The TissueTak™* tendon anchor is the first closed-loop suture based fixation for soft tissue to soft tissue repair of certain types of injuries, designed...