pharmaphorum May 3, 2024
The atrial fibrillation (AFib) detection feature on Apple Watch devices has become the first digital health technology to be qualified under a programme recently introduced by the FDA designed to encourage the development of medtech.
The US regulator published guidance on the Medical Device Development Tools (MDDT) framework last year, a voluntary process that aims to reduce the regulatory burden of evaluating new technologies and speed up the review process.
The approach covers a range of products, including biomarker tests, clinical outcome assessments, and non-clinical tests, and provides an endorsement that the data supports their safety, effectiveness, or performance.
The FDA notes that the Apple Atrial Fibrillation History Feature – which provides a non-invasive way to check estimates of AFib...
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