Medical devices

The US Food and Drug Administration has granted clearance to Vitestro’s Aletta device, easing phlebotomist shortages.

CMS proposes RAPID device coverage pathway to sync evidence with FDA, shorten Medicare timelines, and boost early collaboration with manufacturers.

FDA sets FY 2027 medical device user fees, updating submission and registration costs under MDUFA V and outlining small business reductions.

The US Food and Drug Administration is consolidating key functions, updating reporting structures, and formalizing realignment to improve coordination.

The group urges Canadian government to address affordability, regulatory modernization, and supply-chain resilience.

Health Canada introduces a reliance framework to accelerate access to treatments, beginning with pediatric and veterinary drugs.

The case against a US dental technology company suggests that regulators may be expanding scrutiny into medical device markets and digital health.

What the latest Regulatory Study means for government and innovators, and the challenge of strengthening the UK’s health system and industrial capability.