This section presents the latest developments, inventions, and revolutionary technologies that change the face of healthcare.
Neuvotion, an early-stage medical device company specialising in AI-driven neuromodulation technologies, has received FDA 510(k) clearance for its first product, NeuStim™. This non-invasive, wearable device provides precise electrical muscle stimulation without the need for surgery...
RapidAI, a global leader in AI-driven medical imaging analysis and coordinated care, has received FDA 510(k) clearance for Lumina 3D™. This is the first automated 3D imaging reconstruction solution designed to replace manual processes...
Beckman Coulter Diagnostics has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Access p-Tau217/β-Amyloid 1-42 plasma ratio test. This blood test is designed to help healthcare professionals identify amyloid pathology associated...
Modella AI, a company specialising in generative and agentic artificial intelligence for biomedicine, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its advanced AI-driven diagnostic tool, PathChat DX....
Alleviant Medical Gains FDA Breakthrough Designation for Heart Failure Technology Alleviant Medical, Inc., a private medical device company specialising in no-implant atrial shunt technology for heart failure, has announced two significant developments from the US Food and Drug Administration (FDA). ...
Simpson Interventions has reached significant development milestones in the field of cardiovascular interventional devices. The company’s innovative Acolyte™ Image-Guided Crossing and Re-Entry Catheter System has been granted an Investigational Device Exemption (IDE) by the U.S. Food and Drug Administration (FDA). ...
Zephyrus Innovations, a privately owned medical device company specialising in the design and manufacture of safety syringes and Closed System Transfer Devices (CSTDs), has introduced its latest product, VaporShield....
ONWARD Medical has announced that its ARC-EX System has received de novo classification and marketing authorisation from the US Food and Drug Administration (FDA)....
SeaStar Medical has announced the receipt of Breakthrough Device Designation from the US Food and Drug Administration (FDA). This recognition was granted by the FDA’s Center for Biologics...
IntelliSense™ AFib algorithm uses machine learning to analyse the Pressure Pulse Wave generated during routine blood pressure measurements. This breakthrough incorporates...
