Generative AI Medical Devices Draw FDA Request for Feedback
The FDA has opened a request for feedback on generative AI medical devices, inviting responses from manufacturers, clinicians, researchers, and
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August 29, 2026
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Understanding the SaMD Regulatory Pathway in Canada and the United States
Software that diagnoses, monitors, or treats a health condition carries a different kind of regulatory weight than a physical device. If
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April 25, 2026
How Does FDA Classify Software As A Medical Device (SaMD)?
Nowadays almost all the facets of healthcare are well-equipped with the modern and latest technology tools, including software systems.
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September 15, 2022