The FDA has expanded approval of Instylla's Embrace Hydrogel Embolic System to peripheral arterial bleeding, supported by clinical evidence from the multicentre HALT study.

The FDA has approved Edwards Lifesciences' Pascal Precision system for transcatheter repair of severe tricuspid regurgitation, expanding the device's use beyond mitral valve treatment.

The UK's Medicines and Healthcare products Regulatory Agency has launched its 2030 strategy to modernise regulation of AI-enabled healthcare, medical devices and personalised medicines.

The FDA has approved expanded use of Gore's VIABAHN VBX Balloon Expandable Endoprosthesis as a bridging stent graft for complex endovascular aortic aneurysm repair.

The FDA has granted 510(k) clearances for Endovascular Engineering's Hēlo thrombectomy and blood-return systems, advancing an integrated approach to pulmonary embolism treatment.

The UK government has accepted all 44 recommendations from the National Commission into the Regulation of AI in Healthcare, moving its proposed framework into implementation.

Medovate and JEB Technologies are combining into a single medical-device company under the Medovate name, integrating product development, manufacturing, regulatory and commercial capabilities.

The discussion paper launches a public consultation that could shape future regulatory expectations for AI-enabled medical devices, including premarket evaluation, risk assessment and postmarket monitoring.