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, ...

Thirdwayv and Medcrypt are partnering to provide integrated cybersecurity solutions for connected medical devices throughout ...

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 ...

Thirdwayv Inc., a leader in secure software solutions for connected medical devices, and Medcrypt Inc., a premier provider of ...

Beyond the standards and frameworks, how do secure-by-design tenets become practical, repeatable and scalable?

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 U.S. Food and Drug Administration has flagged three of Philips' medical device facilities after inspections found they ...

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance ...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 ...