Intensive longitudinal sampling enhances subjective data collection by capturing real-time, dynamic inputs in natural settings, complementing traditional methods. This study evaluates the feasibility of using daily self-reported app data to assess clinical improvement among…
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Essential FDA Guidelines Transform AI Medical Devices
Revolutionary Changes in Medical Device Regulation
The U.S. Food and Drug Administration is introducing groundbreaking marketing submission recommendations for AI-enhanced medical devices. These guidelines will provide comprehensive oversight throughout…
Essential TEFCA Healthcare Data Exchange Rules Released
The Department of Health and Human Services (HHS) has unveiled its final rule focusing on healthcare data interoperability, marking a significant milestone in standardizing health information exchange. This…
This month, President-elect Donald Trump appointed former Paypal executive and Silicon Valley-based venture capitalist David Sacks as the White House’s first-ever czar for AI and cryptocurrency. Sacks will be in charge of guiding policy…
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The U.S. National Science Foundation (NSF) is funding a solicitation searching for projects that use the International Space Station (ISS) National Laboratory to advance tissue engineering and mechanobiology research. Through the solicitation, NSF will provide…
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The U.S. National Science Foundation (NSF) is funding a solicitation searching for projects that use the International Space Station (ISS) National Laboratory to advance tissue engineering and mechanobiology research. Through the solicitation, NSF will provide…
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Linus Health, a digital health company focused on early detection of Alzheimer’s and other dementias, announced that its Core Cognitive Evaluation (CCE) platform has obtained European Union (EU) Medical Device Regulation (MDR) Class IIa…
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The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing AI-enabled medical devices.”This final guidance is part…
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The European Union (EU) Medical Device Regulation and In Vitro Medical Device Regulation have introduced more rigorous regulatory requirements for medical devices, including new rules for post-market surveillance. However, EU market vigilance is limited…
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What You Should Know:
– Neoplas Med GmbH, a Greifswald-based medical technology company, has secured an $18M investment from Niterra Ventures Company to further develop and expand its innovative cold plasma wound care technology.
– The…
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