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FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how ...
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FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions
FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management ...
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FDA approves Zeiss Mel 90 excimer laser
The FDA approved the Zeiss Mel 90 excimer laser for the treatment of myopia, hyperopia and mixed astigmatism, according to a ...
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Zeiss gains FDA approval for new excimer laser system for vision correction
The MEL 90 fully integrates into the Corneal Refractive Workflow to offer U.S. surgeons a fast, reliable, and streamlined ...