There has been a surge in academic and business interest in software as a medical device (SaMD). It enables medical professionals to streamline existing medical practices and make innovative medical ...

In a member webinar hosted by techUK, experts from the Medicines and Healthcare products Regulatory Agency (MHRA) provided a comprehensive introduction to the UK’s regulatory framework for software as ...

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 ...

For manufacturers of software-containing devices, a clear understanding of all relevant standards is crucial. This article takes a close look at the past, present, and future state of those standards.

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 ...

eyonis® LCS commercial launch is ongoing in U.S. following FDA 510(k) clearance CE-marking regulatory process is on-going with a decision expected in Q2 2026 that could trigger commercial rollout of ...

Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.

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 ...

Researchers from Tokyo Institute of Technology highlight the diverse and emerging nature of SaMD, its growth potential, and transformative impact on healthcare services, in a new study. There has been ...

SOPHIA ANTIPOLIS, France--(BUSINESS WIRE)--Regulatory News: Median Technologies (FR0011049824, ALMDT, “Median” or the “Company”), developer of eyonis®, a suite of artificial intelligence (AI)-powered ...