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 ...

Draft guidelines aim to align India's medtech software framework with global practices; industry seeks more clarity on AI/ML ...

In the waning days of FDA’s fiscal year, the U.S. Food and Drug Administration (FDA) issued the greatly anticipated final guidance “Clinical Decision Support Software,” which aims to clarify the scope ...

Medical devices are a big business covering a wide range of modalities and applications. To ensure the safety of these devices, the Food and Drug Administration (FDA) publishes guidelines and ...

Despite the fresh set of guidelines, experts said that technologies like AI are increasingly being used in MedTech sector, ...

Dublin, Sept. 24, 2025 (GLOBE NEWSWIRE) -- The "Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course (Nov 10th - Nov 11th, 2025)" training has ...

As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...

Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices ...

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The integration of third-party components and software is an increasingly critical area of security risk that needs more attention from medical device manufacturers, says Anura Fernando, global head ...

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