Generative artificial intelligence powered features such as chatting about what is in pictures, telling children bedtime stories, and imitating podcasters continue to roll out despite fears the ...

On January 6, 2026, the US Food and Drug Administration (FDA) revised its final guidance on Clinical Decision Support ...

Under new Food and Drug Administration (FDA) guidance on "low risk" wearable technology and software, AI-powered health tools are rapidly expanding, leading to major implications for cost, access, and ...

SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, “Median” or “The Company”) announces today that the Company will be sharing ...

On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial ...

Small medtech companies can leverage AI without huge investments to compete with major manufacturers using targeted approaches.

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...

The survey conducted across consumer goods, high tech, industrial equipment, and medical device industries found medical device companies passing up the ability to streamline product operations with ...

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Headlines today obsess over tariffs squeezing margins for medical device manufacturers (MDMs). But while tariffs can shave profits, insecure software can obliterate them—and result in patient safety ...