141: Digital Pathology Tools: How To Get Them FDA Approved?
Description
Why 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 #USCAP2025
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