Regulatory Approvals

The company said the clearance will allow more pharma companies to use Tasso+ for decentralized clinical trials. Tasso received FDA 510(k) clearance for its patch-like blood...

CurveBeam AI, Ltd announced its medical diagnostic software, OssView™, has received US Food and Drug Administration (FDA) Breakthrough Device Designation. OssView calculates a Structural...

The system combines advanced imaging technologies, personalised targeting and new stimulation patterns. Magnus Medical has secured US Food and Drug Administration (FDA) 510(k) clearance for its SAINT...

The new tool measures the diameter of the ventricles of the heart to provide the ratio of the maximum right ventricle diameter compared with...

The miLab Cartridge CER stains and evaluates the cervical cells automatically to support the medical experts’ slide review. Biotech start-up Noul has received CE-IVD marks for its...

eCential Robotics, have announced FDA 510(k) clearance of its 3D imaging, navigation and robotics guidance system, securing the penetration of its unified robotic platform...

 Vesalio announces CE Approval for new NeVa NET™, the first integrated clot micro-filtration technology for stroke thrombectomy patients   NeVa Net™ micro-filtration technology coupled with NeVa’s...

The D-Tect MT accessory recognises movement in three hand areas and does not require cords or sensors. Neuronetics has received 510(k) clearance from the US Food and...

Omnipod 5 is the first tubeless AID System cleared in the U.S. for preschool children Insulet Corporation, the global leader in tubeless insulin pump technology with its...