Diality received FDA 510(k) clearance for its Moda-flx smart, flexible hemodialysis system. California–based Diality designed the system to provide kidney care professionals with a...
Teleflex has been granted 510(k) clearance on its Ringer Perfusion Balloon Catheter (PBC) for Percutaneous Transluminal Coronary Angioplasty (PTCA) procedures by the US Food and...
AliveDx has obtained the European In Vitro Diagnostic Device Regulation (IVDR) CE mark for its microarray immunoassay in allergy diagnostics.
The assay, which detects specific...
AOTI’s NEXA Negative Pressure Wound Therapy (NPWT) system has been granted 510(k) clearance to extend its indications of use by the US Food and Drug...
Camber Spine has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its SPIRA-A Integrated Fixation System for anterior lumbar interbody...
Asensus Surgical received FDA 510(k) clearance for an expanded surgical robot indication. The Research Triangle Park, North Carolina-based company’s Senhance surgical system can now...
Spryte Medical has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its neuro-optical coherence tomography (nOCT) technology.
Designed to revolutionise...
eCential Robotics announced today that it received FDA 510(k) clearance for its spine navigation and robotic-assistance device.Gières, France-based eCential Robotics designed the device as...
Inspire Medical Systems announced its Inspire therapy has secured its CE mark under the EU’s Medical Device Regulation.
Going into effect in 2021, the tighter...
