PureTech Health’s deupirfenidone (LYT-100) has received Orphan Drug Designation to treat idiopathic pulmonary fibrosis (IPF). The…
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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…
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FDA relaxes oversight of AI-enabled devices and wearables
Food and Drug Administration Commissioner Marty Makary.ANDREW CABALLERO-REYNOLDS/AFP via Getty Images Lizzy Lawrence leads STAT’s coverage…
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Key digital and device leaders depart FDA
Mario Aguilar covers technology in health care, including artificial intelligence, virtual reality, wearable devices, telehealth, and…
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FDA Panelists Questioned Antidepressants in Pregnancy. But Doctors Call Them a Lifeline.
If you are pregnant or a new mother who is struggling with depression or anxiety, you…
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FDA pilots allowing digital health devices access to CMS payment program
Dive Brief: The Food and Drug Administration has created a pathway for unauthorized digital health devices…
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FDA launches digital health pilot centred on chronic disease
The FDA’s TEMPO pilot will begin in January 2026. image credit: Photo Agency via Shutterstock.com. The…
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FDA Committee Meets on Generative AI Digital Mental Health Devices
On November 6, 2025, the US Food and Drug Administration (FDA) Digital Health Advisory Committee held…
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Should FDA Clearance and Supply Chain Risks Drive a Reassessment of Baxter International’s (BAX) Digital Health Strategy?
Baxter International recently launched the Welch Allyn Connex 360 Vital Signs Monitor in the U.S., featuring…
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FDA Digital Health Advisory Committee
2025 Advisory Committee Meeting On November 6, 2025, the Digital Health Advisory Committee will discuss and…
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