Regulatory Approvals

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the BioCharge Autobiologic Matrix, a bioresorbable synthetic implant developed by startup Atreon...

CathVision has gained the CE Mark certification for its ECGenius system, enabling the company to market and distribute the system throughout the European Economic...

QuantalX Neuroscience has gained the European CE Medical Device Regulation (MDR) approval for the Delphi-MD, a device for assessing brain health. With this certification in...

Neuvotion received FDA 510(k) clearance for its first product, the NeuStim wearable device. The company designed NeuStim to electrically stimulate muscles dynamically and with...

Ibex Medical Analytics, the leader in AI-powered cancer diagnostics, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Ibex Prostate...

Gyder Surgical, a MedTech company specialising in intuitive, orthopaedic navigation solutions, today announced the 510(k) FDA clearance for the GYDER® Hip System, the world’s...

RapidAI has received FDA 510(k) clearance for Lumina 3D by RapidAI—an industry-first, automated 3D imaging reconstruction solution designed to replace manual workflows with an...

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Imperative Care’s Zoom System, marking an advancement in stroke thrombectomy procedures. The clearance...

Instylla announced it has won FDA 510(k) clearance for its Tembo Embolic System. Bedford, Massachusetts-based Instylla said the Tembo system is a bioresorbable embolisation...