FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...

The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...

The next generation of intelligent medical devices is here. It uses computing hardware, software, and AI across a connected ...

In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...

Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

AUSTIN, Texas and TOKYO, Nov. 24, 2025 /PRNewswire/ -- According to DataM Intelligence, the U.S. Software as a Medical Device (SaMD) Market Size reached USD 205.12 million in 2024 and is forecast to ...

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 ...

FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health ...

For SLAS US 2023, we speak to Guy Starbuck, one of the co-founders at AIQ Global, about how we can utilize AI technology to bring new medical devices to market. Please could you introduce yourself and ...

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 ...