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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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Become a Digital Pathology Trailblazer get the "Digital Pathology 101" FREE E-book and join us!

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Can you still call it “digital transformation” if you’re scanning slides and still tethered to glass?

This special episode, recorded at USCAP and sponsored by MUSE Microscopy, features Dr. Robert Osamura from Japan. We explore how digital pathology is being implemented across Japanese hospitals, how regulations shape adoption, and where AI and tools like MUSE could fit in a geographically complex healthcare system. We also discuss the real-world utility of direct-to-digital tools for intraoperative diagnostics and how AI is changing confidence, not replacing pathologists.

👉 Tune in for an insightful conversation bridging tradition and innovation in digital pathology.

⏱ Highlights with Timestamps

• [00:00] Starting digital pathology with glass is still required
• [02:00] Dr. Osamura’s current practice in a community hospital near Tokyo
• [03:30] Everyday use of digital pathology for biopsy cases
• [04:30] Technical and logistical advantages of digital images
• [05:45] How Japan’s island geography benefits from digital workflows
• [07:15] Government regulations: dual review (glass + digital)
• [08:40] Adoption challenges and culture around microscopes
• [10:00] The psychological shift away from glass reliance
• [11:30] Potential use cases for MUSE technology in Japan
• [13:20] Direct-to-digital for frozen sections and rapid diagnosis
• [15:00] Hospital-to-hospital collaborations in Japan
• [16:30] Reimbursement and scanner costs as limiting factors
• [17:45] AI as a confidence enhancer, not a replacement
• [18:45] Future of pathology as more patient-centered

Episode Resources:

https://musemicroscopy.com/

#sponsored #musemicroscopy #USCAP

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Become a Digital Pathology Trailblazer get the "Digital Pathology 101" FREE E-book and join us!

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Why are so many pathologists still afraid of going digital?

In this USCAP special episode sponsored by Muse Microscopy, I talk with Dr. Sarah Dry, Chair of Pathology and Laboratory Medicine at UCLA, about real-world adoption, AI fear, and how change is best managed when it's people-led.

From her early digital research lab in 2007 to pioneering innovative workflows at UCLA today, Dr. Dry knows how direct-to-digital imaging and AI can enhance, not replace, our work.

🧠 Key Takeaways:

• [00:01:00] Fear of change and pathologist pushback
• [00:03:00] Direct-to-digital imaging & frozen sectios
• [00:05:00] Redefining histotech roles amid tech shortages
• [00:08:00] CAP standards, tissue storage & digital-first futures
• [00:12:00] Specialty-specific barriers to adoption
• [00:15:00] Why AI is a pathologist extender, not a threat
• [00:18:00] What AI can automate—cell counts, GI screenings & reports
• [00:20:00] Managing change and getting early adopters onboard
  
  

🎧 Tune in to hear how digital pathology becomes scalable, without losing the people at its core.

#DigitalPathology #AIinPathology #ChangeManagement #PathologistLeadership #WomenInSTEM

Support the show

Become a Digital Pathology Trailblazer get the "Digital Pathology 101" FREE E-book and join us!