Regulatory Approvals

Realize Medical announced that it received FDA 510(k) clearance for its Elucis virtual reality (VR) software for surgical planning. The Ottawa, Canada-based startup designed Elucis...

The Abbott system previously earned approval for chronic pain in 2019, and adds another option for a patient population with no disease-modifying agents available...

Varian, a Siemens Healthineers company, has announced that the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) for the pivotal...

PENTAX Medical INSPIRA combines the latest functionalities in one solution, which can be controlled with a touch panel. HOYA Group division PENTAX Medical has received CE marks for...

Abbott (NYSE:ABT) announced that it received FDA approval for its latest-generation transcatheter aortic valve implantation (TAVI) system. The company designed the Navitor system for treating people...

EndoTheia Inc. Announces FDA Breakthrough Device Designation for Technology to Improve Endoscopic Surgery EndoTheia’s Breakthrough Device leverages foundational technology that was originally invented at Vanderbilt and...

 Opticyte, a medical device start-up, announced that its Cell O2 Patient Monitor received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA)...

The TightRope implant is claimed to be the first fixation device for ACL injuries approved for paediatric application. Arthrex has secured approval from the US...

NanoHive Medical has received 510(k) Clearance from the U.S Food and Drug Administration (FDA) for its Hive™ Standalone Cervical System. The implant system features...