Mass layoffs at the U.S. Department of Health and Human Services (HHS), including the Food and Drug Administration (FDA), will impact the medical device regulatory process, says Ben Wolf, partner in Alston & Bird’s…
Continue Reading
Industry-Government Consensus Building
The healthcare sector is witnessing a remarkable convergence between industry innovators and government regulators in defining and implementing responsible artificial intelligence. Brian Anderson, CEO of Coalition for Healthcare AI, emphasizes the critical…
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…
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…
Continue Reading
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…
Continue Reading
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…
Continue Reading
The European Union’s recently adopted Artificial Intelligence (AI) Act is the first comprehensive legal framework specifically on AI. This is particularly important for the healthcare domain, as other existing harmonisation legislation, such as the…
Continue Reading
Mickey Tripathi, U.S. National Coordinator for Health IT, and Troy Tazbaz, the U.S. Food and Drug Administration’s digital health director, stepped down from the Coalition for Health AI last week. While the announcement followed concerns…
Continue Reading
What You Should Know:
– Mika Health, a leading developer of digital therapeutics for cancer patients, announced a collaborative initiative called “UNITE” alongside pharmaceutical giants AstraZeneca and Daiichi Sankyo.
– The strategic initiative signifies a commitment…
Continue Reading
The Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled its regulatory roadmap for the development of new and robust regulations for medical devices in the UK.The plans have been laid out to protect…
Continue Reading
