Tandem Diabetes Care issued an urgent medical device correction to upgrade the software of its Tandem Mobi insulin pumps that ...
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 ...
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 ...
The software supply chain is critical to ensuring a secure medical device that can prevent injury, according to Gregg Van Citters, MS, PhD, a principal software quality engineering consultant at ...
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 ...
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 ...
In medical-device software, an update isn’t just a new feature — it can directly affect patient safety. Every code change in a surgical-laser system must be fully traceable to its verification and ...
The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...
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 ...
Changes to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are in the pipeline, but a speaker ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results