Control Bionics has received approval from the Centers for Medicare & Medicaid Services (CMS) for a new Healthcare Common Procedure Coding System (HCPCS) code...
The US Food and Drug Administration (FDA) has granted market clearance to a medical gel designed to stem bleeding in emergency situations.
The FDA has...
Stereotaxis has received a CE mark in Europe for its minimally invasive endovascular robotic system, GenesisX.
The company has now set its eye on securing...
Surgical Planning Associates received FDA 510(k) clearance for its HipInsight 2.0 mixed-reality guidance system. Boston-based Surgical Planning Associates developed the system for hip arthroplasty...
US-based fluid control company, Pneuma Systems, has become the latest company to be admitted onto the US Food and Drug Administration’s (FDA) Safer Technologies...
AventaMed, a Karl Storz company, received FDA 510(k) clearance for its Solo+ ear tube placement system. Solo+ combines multiple steps into an all-in-one device...
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...
