The new guidance reshapes the predicate landscape for cuffless BP. We map your technology, claims, and clinical evidence against both pathways — and tell you which one your competitors will be forced into.
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We secured breakthrough status and drove a 3-month FDA submission for an AI breast-risk SaMD.
We isolated Neosoma's new CNN for FDA review, won clearance in 3 months, and built a framework for every product after.
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A deep dive into the 97 cleared cardiovascular AI/ML SaMD devices, the four archetypes that organize them, and what they reveal about the future of FDA-cleared software.
Yujan Shrestha
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