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 climb to USD 715.00 million by 2033, expanding at a ...

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 ...

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 ...

The Central Drugs Standard Control Organisation (CDSCO) has issued a draft guidance document on medical device software to bring more clarity on the regulatory aspects of their usage. The document, ...

Labeling AI mental health chatbots as medical devices would stymie progress in helping people in need with simple tools that ...

SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, PEA/SME eligible, “Median” or “The Company”), a leading developer of eyonis™, a suite of ...

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on Medical Devices Software, under the Medical Devices Rules (MDR), 2017, to bring in specific regulatory ...

Medical devices have to be designed so that people can use them easily and reliably. Human factors considerations have gained increased attention since the release of FDA's guidance document, Medical ...