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The FDA has published overdue draft guidance on developing diversity action plans for clinical trials, moving the agency a step closer to the statutory mandate that all phase 3 trials include such plans. Read More
Identifying disease biomarkers in rural and medically underserved populations through breath-based diagnostics devices is the goal of the FDA’s partnership with the Bill & Melinda Gates Foundation, CDRH announced Wednesday. Read More
The FDA has established an Artificial Intelligence Program with a focus on six research topics that delve into the far-reaching implications of medical devices powered by AI and machine learning. Read More
The Apple Watch’s atrial fibrillation (AFib) history feature is now qualified as the first digital health technology under the FDA’s Medical Device Development Tools (MDDT). Read More
With an aim of supporting patients, medical device developers and policymakers, the CDRH has launched a new initiative to deliver virtual reality-enabled models for use in the development of home-based care solutions. Read More
Can remote cognitive testing via smartphones yield reliable and valid data to evaluate people for a type of dementia? Findings of a study of 360 individuals spanning over four and a half years indicate the answer is yes. Read More