141: Digital Pathology Tools: How To Get Them FDA Approved?

Send us Fan MailWhy 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!