Validated biomarkers help physicians identify patients that will benefit most from certain treatments, but implementation challenges remain.

Philips has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Verida spectral CT system.

CorTec's BCI aims to differentiate itself by offering brain-based communication alongside therapeutic neurostimulation.

Phantom Neuro has secured approval to initiate a trial of its minimally invasive muscle-machine interface in Australia.

J&J has reported interim 12-month results from the VARIPURE study, assessing the effectiveness and safety of its Varipulse PFA platform in first-time users.

Boston Scientific shared the results during a late-breaking presentation at this year’s EHRA congress in Paris, France.

Sibel Health has received the US FDA 510(k) clearance for ANNE Maternal, a fully wireless maternal-foetal monitoring platform.

ProSomnus Sleep Technologies has received the US Food and Drug Administration (FDA) Class II 510(k) clearance for its RPMO₂ OSA device.

Click's CT-155 commercialisation plan comes as regulatory-approved digital therapeutics experience strong market growth.

The device is designed to facilitate safe and reproducible left-heart access. Credit: MMD Creative / Shutterstock.com. Protaryx Medical has received the US Food and Drug Administration (FDA) 510(k) ...

The MHRA has secured a $4.8m funding increase over three years to expand the AI Airlock programme, the UK’s regulatory sandbox for AIaMD.

Heartflow alleges that after working as its consultant, Cleerly’s CEO launched a competing enterprise “built upon” Heartflow’s innovations.