Key market opportunities lie in developing medical software and healthcare apps with a strong focus on safety, quality, and effectiveness. Leveraging AI/ML technologies, understanding clinical ...

In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...

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 ...

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 ...

The data reveals key market opportunities in enhancing compliance through expertise in PMS, PMCF, and vigilance for digital health technologies. Emphasizing real-world data, risk management, and ...

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 ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

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 ...

Discover how medical 3D printing creates patient-specific devices and custom prosthetics. Read our guide to clinical ...