AI’s reach depends on the environments in which it operates as well as how it is developed and deployed, highlighting a fundamental debate on whether we should push for regulation or opt for free-market-driven deregulation.
Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has been a top priority and now, more companies are moving toward EU MDR sustainability. As we look ahead to an unpredictable year in medtech, three areas stand out as opportunities for medtech to drive meaningful progress. AI, recall management, and regulatory intelligence could be key differentiators for medtechs — if approached strategically.
CitiusTech Senior VP and Market Head, Healthcare Providers, John Squeo, shares five game-changing shifts that will redefine the future of US healthcare and unlock a more streamlined, accessible and patient-centric system.
The future of healthcare lies in the successful integration of workflow automation and advanced technologies. As the buzz-word salad of AI, such as NLP, LLMs, Gen AI, RPA, etc continue to evolve, their potential to revolutionize healthcare workflows will only increase.
Researchers have developed a new machine-learning model that can precisely make prognosis predictions for patients with osteosarcoma, based on the density of viable tumor cells post-treatment.
“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.
