FDA guidance eases wearables oversight. But experts have questions about what’s next.
Amid a deregulatory push by the Trump administration, the Food and Drug Administration is scrutinizing its digital health policies. The agency suddenly issued a pair of guidances earlier this month,…
Key digital and device leaders depart FDA
Mario Aguilar covers technology in health care, including artificial intelligence, virtual reality, wearable devices, telehealth, and digital therapeutics. His stories explore how tech is changing the practice of health care…
FDA Launches TEMPO Digital Health Pilot
The U.S. Food and Drug Administration announced the new Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a voluntary pilot designed to promote access to certain digital health…
FDA introduces TEMPO model to complement CMS ACCESS model
The Food and Drug Administration plans to select about 40 devices not yet cleared by the agency to receive special agency discretion to participate in the new chronic care Advancing…
Former top FDA digital leader lands at Mayo Clinic
Mario Aguilar covers technology in health care, including artificial intelligence, virtual reality, wearable devices, telehealth, and digital therapeutics. His stories explore how tech is changing the practice of health care…
HHS terminations impact AI regulation at FDA
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