The FDA has quietly authorized more than 1,000 medical devices incorporating artificial intelligence or machine learning, marking a significant growth of AI in healthcare. The agency’s AI/ML ...

Numerous medical devices sold in the United States are subject to active recalls. If you have a medical device that is subject to an active recall, ...

Some solutions are prioritizing the use of medical devices designed for low-resource settings, the development of cutting-edge diagnostics, and digital health tools to improve treatments and outcomes.

ECRI, the patient safety organization, has published its annual list of the 10 health technology hazards it's watching in 2024. WHY IT MATTERS As part of its safety-focused mission, the nonprofit ECRI ...

The U.S. Food and Drug Administration (FDA) now provides a list of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices that are legally marketed in the United States ...

Have a plan for your device whether you plan to shelter at home or evacuate during the power outage. “People who rely on medical devices, like CPAP machines, oxygen tanks or concentrators, and people ...

Device lobbyists’ priorities contrasted with patient advocates, who sought an increase in user fees and more funds for ...

Explore the full 2022 list of Fast Company’s Most Innovative Companies, 528 organizations whose efforts are reshaping their businesses, industries, and the broader culture.

Why Cresilon, Audicus, ivWatch, and GrayMatters Health are among Fast Company's Most Innovative Companies in medical devices for 2024.

Are you designing oncology imaging systems? Discover how AI and GenAI can streamline detection, enhance diagnostic accuracy, ...

Just as many medical devices are still operated by PCs using the geriatric Windows XP, old code, open or otherwise, might have been birthed before the times of scrutiny for cyber safety.

Dr. Jeffrey E. Shuren in 2022. He presided over the F.D.A.’s. medical device division for 15 years, supervising about 2,500 staff members and overseeing a budget of about $790 million.