AdvaMed has praised the CMS' plans to establish a framework to simplify the exchange of healthcare data between patients and providers.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for CardioTag, Cardiosense’s multimodal, wearable sensor.

Medical device database EUDAMED is viewed by the European Commission as an integral part of the EU MDR and EU IVDR’s implementation.

Natera has announced the initiation of the Phase II TEODOR trial of its Signatera test aimed at certain breast cancer patients.

Axonius has acquired New York-headquartered healthcare cybersecurity firm Cynerio in a $100m cash and stock deal.

Johnson & Johnson MedTech has launched the VIRTUGUIDE System, an AI-powered Lapidus solution to minimise bunion surgery complexities.

ALZpath’s pTau217 antibody is drawing significant attention at this year’s Alzheimer's Association International Conference (AAIC), taking place in Toronto, Canada, from 27-31 July. The biomarker ...

GE HealthCare and Ascension have partnered to improve clinical and operational outcomes within the latter’s national network.

Stereotaxis has received US Food and Drug Administration (FDA) clearance for its electrophysiology (EP) catheter MAGiC Sweep.

The advent of artificial intelligence (AI) at the US Food and Drug Administration (FDA) is changing the complexion of the regulatory approval process for medical devices.

Olympus and private equity firm Revival Healthcare Capital have co-founded a new endoluminal robotics startup named Swan EndoSurgical Robotics.

Medtronic's trial of INFUSE Bone Graft in the TLIF procedure for use in spine surgery achieved predefined early success criteria.