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 Prior FDA draft guidance has ...
The U.S. Food and Drug Administration is seeking public comment on new recommendations for nonclinical and clinical performance testing to support premarket submissions for pulse oximeters for medical ...
Expediting regulatory guidance for RWE in medical devices: Why it matters for patients Real-world evidence (RWE) can enhance our understanding of the safety, performance, and effectiveness of medical ...
On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The ...
Modern devices feel fast and responsive when new, but many users notice gradual sluggishness after months or years of use. The reason why gadgets slow down is not random or imagined—it follows ...
The findings of a recent quarterly report on mobile device performance and health by analysts at Blancco Technology Group suggest iPhones have been overtaken by Android smartphones in terms of ...
The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices. Officials say the move is intended to speed innovation while maintaining ...
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