
FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline
The FDA plans to expand generative AI capabilities—across all centers using a secure, unified platform.
The FDA plans to expand generative AI capabilities—across all centers using a secure, unified platform.
MTI Viewpoint: I expect fundamental changes to our medical device ecosystem; not all companies will survive them. The ability to consistently use AI will also determine who will be among the survivors and even the winners. AI will not only be part of the devices but also an internal tool.
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.
Advancements in cardiac care and novel therapies are transforming cardiac medical devices, providing new solutions for millions affected by heart disease globally.
What’s getting R&D attention? The impact of upcoming regulations, A.I., new cybersecurity risks, developments in battery power and innovation, collaborative efforts, and other impacts on the industry in the year ahead.
How will 2025 rise to the challenge of meeting the demand for personalized healthcare? A perspective on the transformative advancements of 2024—highlighting the impact of AI, robotics, and digital health as they begin to reshape the healthcare landscape.
Cardiovascular conditions are the leading cause of death. Fortunately, industry leaders are discovering innovative ways to diagnose and treat them. See how mobile apps and AI will change this field in 2025 and beyond.
MTI Viewpoints are insights shared by industry relative to healthcare and the advancement of medical technology.
Billions of dollars are lost annually in medical billing errors resulting from data entry mistakes, outdated coding practices, and duplicated charges. Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing the process of claims processing, diagnostics, eliminating errors, streamlining workflow, and increasing the accuracy of claims submissions. Together with human oversight to ensure precision and safety, AI augments healthcare professionals to improve patient care and outcomes.