The integrated solution delivers a shift-left approach to cybersecurity, enabling executive teams to proactively embed security, quality, and compliance from early development to post-market. When ...

Enlil and Interlynk join forces to transform SBOMs into dynamic tools for managing cybersecurity in medical devices.

Over the years, medical devices have become increasingly dependent on software. They have evolved from the use of a metronome circuit for early cardiac pacemakers to functions that include ...

Software designers are testing specialized AI-powered chatbots that can give medical advice and diagnose conditions — but questions abound about accuracy.

Medical software is the backbone of modern healthcare, supporting electronic health records (EHRs), diagnostic systems, imaging technologies and embedded software in medical devices like pacemakers ...

In 2023, the FDA identified 62 medical device recalls with 42 identified to date in 2024. Most recently, Tandem Diabetes Care recalled its Apple iOS app after over 200 reported injuries. While the ...

India has brought AI-based diagnostic software under medical device regulations, mandating government licences and clinical ...

On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical ...

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

A recent article[1] authored by Haider J. Warraich, MD[2]; Troy Tazbaz[3]; and Robert M. Califf[4], MD in the Journal of the American Medical Association, reviews the history of artificial ...