Regulatory Approvals

MicroPort CardioFlow Medtech Corp. today announced that it received CE mark for its second-generation aortic valve implant.The VitaFlow Liberty transcatheter aortic valve implant (TAVI)...

Xeltis announced it received FDA investigational device exemption (IDE) to begin a pivotal study of its restorative vascular access conduit. aXess enables the creation...

Aktiia has won CE marking for its optical blood pressure measuring technology that does not require calibration from a traditional cuff, opening integration into...

Becton, Dickinson and Company (BD) has obtained 510(k) clearances from the US Food and Drug Administration (FDA) for its new fingertip blood collection device,...

Light field technology company Evolution Optiks has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its LFR-260, which is claimed...

Intuitive announced the FDA cleared a labelling revision for its da Vinci X and Xi surgical robotic platforms. It is based on real-world evidence...

Moon Surgical received FDA clearance for the commercial version of its Maestro surgical robot system. The Paris-based company designed Maestro to provide an accessible,...

Pre-clinical medical device company Microbot Medical has obtained US Food and Drug Administration (FDA) approval to proceed with its pivotal human clinical trial for...

Zeto announced received FDA 510(k) clearance for its One product for electroencephalography (EEG) brain monitoring. Santa Clara, California-based Zeto designed One to feature a...