Apple needs more revenue from Wearables, and new artificial intelligence (AI) smart devices could build positive buzz for ...
GE HealthCare continues to lead the industry in artificial intelligence (AI) innovation, topping a U.S. Food and Drug Administration list of AI-enabled medical device authorizations, with 115 ...
The U.S. Food and Drug Administration (FDA) is seeking comments on methods of assessing the real-world performance of AI-enabled medical devices, including generative AI. Prior FDA draft guidance has ...
On August 18, 2025, the Food and Drug Administration (FDA) issued guidance (Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device ...
The FDA continuously updates its list of devices that utilize AI and machine learning (ML) technologies, which has shown exponential growth since 2018. Algorithms for stroke, breast cancer, and lung ...
The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing ...
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Prediction: This Artificial Intelligence (AI) Company Will Power the Next Era of Smart Devices
Right now, Arm Holdings gets most of its revenue from the smartphone market. But the adoption of its chip architecture is gaining traction in edge AI devices. The company's new chip designs should ...
Artificial intelligence-enabled medical devices with no clinical validation were more likely to be the subject of recalls, according to a study published in JAMA Health Forum. The study, published on ...
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