A university 3D printing lab in Milan has become a certified manufacturer of custom-made medical devices under the EU MDR, ...
ESTRO Signs Joint Statement on AI-Enabled Medical Technologies Regulation / AI Act, artificial intelligence, cancer, ESTRO, ...
Permitting medical device manufacturers to submit bulk summary reports of adverse events to the U.S. Food and Drug ...
Medical Device Network on MSN
Podcast: The FDA’s GenAI proposal: evolving regulation for an evolved medtech era
Dennis Gucciardo, partner at Morgan Lewis, weighs the benefits and potential rationale behind the FDA's discussion paper on ...
The Consumer Product Safety Commission is easing safety requirements for fuel-additive containers, a move the agency says will save businesses an estimated $545.7 million in annual regulatory costs.
The UK has chosen not to adopt an all-encompassing set of legislation similar to the EU’s AI Act. Instead, the UK Government has consistently ...
Artificial intelligence is moving from the margins of healthcare into its everyday operation — from tools that summarise clinical records and ...
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has adopted a multi-year strategy aimed at ensuring ...
The FDA's discussion paper around a proposed approach to GenAI-based medech regulation is open to stakeholder feedback until 19 October 2026.
Smart homes, urbanization, construction and energy-efficiency mandates drive demand, creating opportunities in connected, safety-focused devices and renovations.Dublin, Oct. (GLOBE NEWSWIRE) -- ...
The Therapeutic Goods Administration has found that eight of 12 digital scribe products reviewed have functions likely to ...
Researchers uncovered a spyware campaign targeting Al Jazeera devices through online ads, exposing how advertising ...
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