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John Bertrand on FDA Approval, CMS Reimbursement, and AI Healthcare Reality
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Guest: John Bertrand, former Digital Diagnostics Episode Description Joe Grogan sits down with John Bertrand, a veteran healthcare technology executive who scaled Digital Diagnostics to 75 health systems and achieved the first FDA approval and CMS reimbursement for an autonomous AI diagnostic device without a physician in the diagnostic loop. Bertrand reveals the harsh realities of bringing AI innovation to market: FDA and CMS regulatory frameworks are built for traditional medical devices and physician-driven care, not autonomous AI diagnostics. The conversation covers the shocking CMS reimbursement draft that came in 40-60% below cost of goods sold, the massive first-mover disadvantage in…