Obvius Robotics announced the FDA granted breakthrough device designation for its Certa access system for central venous catheterisation (CVC).
CVC procedures require access to one...
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 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...
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...
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...
