The FDA has removed pediatric ventricular assist bypass devices (VADs) from its device shortage list in an update this month.
ECRI, the patient safety organization, has published its annual list of the 10 health technology hazards it's watching in 2024. As part of its safety-focused mission, the nonprofit ECRI conducts ...
A popular medical monitor is the latest device produced in China to receive scrutiny for its potential cyber risks. However, it is not the only health device we should be concerned about. Experts say ...
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-Enabled ...
The number of medical devices with artificial intelligence technology has risen sharply in the past decade. The Food and Drug Administration has authorized 950 AI or machine learning-enabled devices ...
FDA's March 2025 recalls include Medline catheters, Integra wound products, Insulet Omnipod 5 Pods, Intuitive Surgical staplers, and B.Braun bloodlines.
Increased R&D investments to integrate AI on devices across disease states designed to boost productivity, efficiency, and diagnostic confidence for healthcare professionals, and drive the company’s ...
New Delhi: In an attempt to bring regulatory uniformity in medical devices, the government plans to classify around 1,178 medical devices into four categories based on their risk approach under the ...
The growing prevalence of chronic diseases like cancer and diabetes is driving increasing innovation in medical device technology. In 2024 alone, 30 new devices were approved by the US Food and Drug ...
The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...