Stimvia plans to enter US neuromodulation market after MDR certification
Stimvia is set to enter the multi-billion dollar neuromodulation market in the United States with its innovative URIS device. The Czech company says this...
Accuray wins CE mark for new helical radiation delivery system
Accuray received CE mark approval for its Helix CT-guided helical radiotherapy system. The Madison, Wisconsin-based company designed Helix to deliver high performance and high...
Obvius Robotics earns FDA breakthrough nod for Certa access system
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 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...