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SaMD vs SiMD: Quick Comparison for Medical Devices
SaMD (Software as a Medical Device) is software with a medical intended use that works independently of device hardware . SiMD...
Jun 17, 20255 min read
The Gentle Singularity in Life Sciences: What Sam Altman's AI Timeline Means for Medical Innovation
Sam Altman’s June 10, 2025 essay, “ The Gentle Singularity ,” sketches a near-term AI timeline—2025 agents doing real cognitive work,...
Jun 16, 20254 min read
510(k) vs De Novo vs PMA: How to Choose the Right Pathway (2025)
Choosing an FDA pathway hinges on risk, novelty, and predicates. Use 510(k) when a suitable predicate exists for the same intended use...
Jun 12, 20254 min read
Good Machine Learning Practice (GMLP): What It Is & Who Must Follow It
Good Machine-Learning Practice (GMLP) = ten regulator-endorsed principles for AI/ML medical devices, covering data, design, validation,...
Jun 12, 20253 min read
Clinical Evidence for SaMD: Valid Association, Analytical & Clinical Validation
To structure SaMD clinical evidence, build three pillars: valid clinical association (link SaMD output to the condition), analytical...
Jun 10, 20253 min read
FDA Software Validation 2025: What Evidence to Show
In 2025, FDA reviews a risk-based software evidence package per the Device Software Functions (DSF) guidance: choose Basic or Enhanced...
Jun 5, 20252 min read
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