Roche’s Elecsys pTau181 test has secured CE Mark approval, marking a development in ruling out Alzheimer's disease.

The European Commission (EC) has approved a €403m ($473.3m) public funding package to support medical device innovation in the bloc.

Nestmedic has chosen Curavit Clinical Research to spearhead the US clinical study of the remote prenatal monitoring solution, PregnaOne.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has shared new proposals intended to improve access to the latest medical device technologies for UK patients.

Healthcare investment company ARCHIMED’s affiliate is set to acquire ZimVie for an enterprise value of around $730m.

Despite its clinical importance, the global ICP monitoring market remains small, slow-growing, and resistant to disruption.

The implications of medical device regulations on market entry strategies are profound. Credit: Doidam 10/Shutterstock.com. The medical devices industry is always undergoing significant regulatory ...

RadNet's subsidiary DeepHealth has concluded the previously announced acquisition of iCAD in a deal valued at $103m.

The US Court of Appeals has overturned a $106.5m ruling wherein a California court jury found that Medtronic infringed on a heart valve replacement method developed by Colibri Heart Valve.

DeepQure has secured approval from South Korea's MFDS for the trial of its HyperQure, aimed at treating atrial fibrillation (AF).

Medtronic has secured EU CE mark approval for LigaSure RAS, a vessel-sealing instrument for use with the company’s Hugo robotic-assisted surgery (RAS) system.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Tempus AI’s ECG-Low (ejection fraction) EF software.