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Medical Technology and Policy · uk

How Can Medical AI Stay Safe After Deployment? UK Launches Regulatory Reform and Third Sandbox Phase

The UK has accepted all 44 recommendations from its commission on medical AI regulation, extending safety assessment to the periods when products are used and updated. Applications have also opened for the third phase of AI Airlock, which will test how to track risks across different clinical settings and ensure safety information reaches healthcare professionals and patients promptly.

Medical Technology · us

A Further Step Toward Assessing Myocardial Infarction at Home: HeartBeam Receives FDA Breakthrough Device Designation

Bringing ECGs to where symptoms occur is the gap in care HeartBeam aims to fill. Breakthrough Device designation accelerates communication on development and review, but following a 134-patient pilot study, a pivotal trial is still needed to validate the use; the current cleared indications do not include myocardial infarction assessment.