Regulatory Approvals

India-based AI firm Qure.ai has announced US Food and Drug Administration (FDA) clearance of its computed tomography (CT) imaging solution designed to help radiologists...

Procept BioRobotics received FDA 510(k) clearance for its next-generation Hydros robotic surgery system. Hydros delivers the San Jose, California-based company’s Aquablation therapy. The company...

AlgoDx, a leading medical AI company with EU and UK-approved ML-based software for sepsis prediction in commercial use, has announced that it has received...

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...