Send us a textWhy do so many digital pathology tools stall before they ever reach patients? In this USCAP 2025 special sponsored by Muse Microscopy, I talk with Esther Abels, founder of SolarisRTC, regulatory strategist, and the force behind the first FDA-cleared whole slide imaging system.We break down what startups and established companies must do from day one to succeedbin getting their devices through the FDA. Hint: regulatory strategy isn’t a final step—it’s your starting line.🧠 What You’ll Learn:[00:01:00] Why regulatory planning must start at inception[00:03:00] How Esther helped Philips get the first scanner FDA cleared[00:05:00] Clinical study design, documentation, and risk strategy[00:08:00] Timeline expectations for clearance and review[00:10:00] The role of consultants vs. internal regulatory teams[00:13:00] Using meta-analysis, synthetic data, and publications[00:15:00] How the DPA is driving system decoupling & AI regulatory clarity🎧 Tune in to learn how to build compliance into innovation—from tissue imaging to AI-powered diagnostics. #DigitalPathology #RegulatoryStrategy #FDAApproval #ClinicalInnovation #PathologyTools #MUSEmiscroscopy #sponsored #USCAP2025Support the showGet the "Digital Pathology 101" FREE E-book and join us!

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