Regulatory Approvals

Clearmind Biomedical wins FDA clearance for Neuroblade minimally invasive neuroendoscopy tech

Clearmind Biomedical received FDA 510(k) clearance for its Neuroblade neuroendoscopy system. The novel system enables minimally invasive procedures with integrated features such as visualization,...

SurGenTec wins FDA nod for bone marrow aspirate kit

SurGenTec received FDA 510(k) clearance for its proprietary B-MAN bone marrow aspirate kit. The Boca Raton, Florida-based company says its B-MAN kit offers a...

FDA clears AISAP’s AI-powered Cardio platform

The US Food and Drug Administration (FDA) has issued 510(k) clearance for AISAP’s AI-powered CARDIO point-of-care ultrasound (POCUS) diagnostic software. The cloud-based platform is designed...

FDA clears Qure.ai’s lung nodule imaging suite

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...

FDA clears next-gen surgical robot from Procept Biorobotics

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 receives FDA clearance for sepsis detection software

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’ NeuroNode sensor secures CMS approval for HCPCS code

Control Bionics has received approval from the Centers for Medicare & Medicaid Services (CMS) for a new Healthcare Common Procedure Coding System (HCPCS) code...

Cresilon secures second clearance for blood stemming Traumagel

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’ endovascular robotic system wins EU clearance

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...
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