<a target="_blank" href="https://www.buzzsprout.com/twilio/text_messages/410071/open_sms">Send us a text</a> Why do so many digital pathology tools stall before they ever reach patients?  In this USCAP 2025 special sponsored by <a href='https://musemicroscopy.com/'>Muse Microscopy</a>, 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:<ul><li>[00:01:00] Why regulatory planning must start at inception</li><li>[00:03:00] How Esther helped Philips get the first scanner FDA cleared</li><li>[00:05:00] Clinical study design, documentation, and risk strategy</li><li>[00:08:00] Timeline expectations for clearance and review</li><li>[00:10:00] The role of consultants vs. internal regulatory teams</li><li>[00:13:00] Using meta-analysis, synthetic data, and publications</li><li>[00:15:00] How the DPA is driving system decoupling & AI regulatory clarity </li></ul>🎧 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 <a rel="payment" href="https://www.buzzsprout.com/410071/support">Support the show</a>Become a Digital Pathology Trailblazer get the <a href='https://digitalpathology.club/digital-pathology-beginners-guide-notification'>"Digital Pathology 101" FREE E-book and join us!</a>

Podurama

Home

Trending

Personal

Your Podcasts

New Episodes

My Files

Favourite Episodes

Tags (Folders)

Recently Played

Bookmarks

Followed Playlists

141: Digital Pathology Tools: FDA Approved

Digital Pathology Podcast

AI Chapters

AI Insights

Reviews