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

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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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