On July 14, the U.S. Food and Drug Administration (FDA) announced it is seeking public input regarding the patient safety impacts of certain medical software functions excluded from the definition of ...
On January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and ...
The HubKey is a docking solution that not only provides additional connectivity options for a laptop, but is also an input device that is being financed as part of a Kickstarter campaign. The device ...
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