Panelists discuss how prescription digital therapeutics differ from traditional pharmaceuticals by following FDA medical ...
Opinion: Companies developing AI-enabled health-care technologies should treat regulatory and IP strategies as parallel, ...
Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves ...
The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical technologies. This article examines the 2024 guidelines from the U.S. Patent and ...
The International Medical Device Regulators Forum (IMDRF) has issued a draft guidance for predetermined change control plans ...
Beyond the standards and frameworks, how do secure-by-design tenets become practical, repeatable and scalable?
Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. Medical device cybersecurity is a dynamic and evolving space. As more devices enter the ...
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance ...
Health Team FDA isn't doing enough to prevent medical device hacking, HHS report says The US Food and Drug Administration is not doing enough to prevent medical devices such as pacemakers and insulin ...
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