Add Yahoo as a preferred source to see more of our stories on Google. Abbott’s range of paediatric heart treatments also includes the Masters HP 15mm mechanical heart valve. Credit: Michael Vi / ...

Paris, France and Cambridge, Massachusetts-based Voluntis, which makes companion software for medical devices or medications, has received both FDA clearance and the CE Mark for a type 2 diabetes ...

GE HealthCare Technologies Inc. GEHC recently announced that it has obtained FDA 510(k) clearance and CE Marking for its Allia Moveo, enabling commercialization of its latest interventional imaging ...

First-and-only test of its kind approved under new European Union regulations expands access to personalized cancer care for patients across the EU This in vitro diagnostic (IVD) assay, which has been ...

Becton, Dickinson and Company (BD) has secured 510(k) clearance from the US Food and Drug Administration (FDA) and CE marking under the European Union's In Vitro Diagnostic Regulation (IVDR) for its ...

iSonea, the Maryland-based startup working on smartphone-based asthma monitoring, says it will launch its AirSonea connected hardware device in Australia prior to launching in the US. The company's ...

New Panther Fusion Gastrointestinal Bacterial and Expanded Bacterial Assays deliver tailored, actionable diagnostic results to support fast and informed patient care A variety of complex factors, ...

First and only delivery system designed specifically for premature infants with a patent ductus arteriosus (PDA), a life-threatening opening in their heart New delivery system enables precise ...

Corporate image representing Global Certification Development Research Institute (GCDRI) delivering ISO certification consulting, FDA registration support, and CE Marking advisory services for ...

The assay measures three host-immune proteins to indicate the likelihood of bacterial or viral infections, and is validated for use on Beckman Coulter immunoassay analyzers.