“Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products” and “Artificial Intelligence in Drug Manufacturing” were developed to support the use of AI/ML while addressing concerns related to security, bias and risk, and spur feedback and discussion from stakeholders.
The UK MHRA has published “Software and Artificial Intelligence as a Medical Device.” The guidance document assembles previous guidances and regulatory requirements for SaMD and AIaMD devices seeking commercialization in the UK market.
The CDRH notes that the goal of the guidance is to put safe and effective advancements in the hands of healthcare providers and users more quickly to help increase the pace of medical device innovation in the U.S. and enable more personalized medicine.
The world of medicine has long centered on the central maxim laid out in the Hippocratic Oath, “Do no harm.” When we look at the growth of AI in health care, I say let’s also include a 21st-century addendum, “Do not deceive.”
The MDDT program was developed in collaboration with the National Institutes of Health’s (NIH’s) National Institute of Drug Abuse (NIDA), National Institute of Dental Craniofacial Research (NIDCR) and National Cancer Institute (NCI) as a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices.
AI can support device innovation and surgical training, but it requires data and collaboration.
How can AI become a beneficial medical device manufacturing technology? This article reviews some examples of how it excels.
2022 is now upon us, hopefully marking the end of a very disruptive couple of years. Global challenges, from supply chain shortages to remote services, have driven digital innovation and change in the way we work across all sectors. The medical device industry is no different and going forward, having learned from the experiences of 2021.
Ultrasound technology has gone through a massive, recent progression. This article reviews four trends defining these enhancements.
Fueled by the need to provide quality care during a global pandemic, healthcare stakeholders are acting quickly to identify new opportunities and overcome challenges.