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HBO and The Ringer's Bill Simmons hosts the most downloaded sports podcast of all time, with a rotating crew of celebrities, athletes, and media staples, as well as mainstays like Cousin Sal, Joe House, and a slew of other friends and family members who always happen to be suspiciously available.
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This week's episode covers the first FDA-approved ingestible gas-sensing capsule, AI-powered endoscopy with spatial computing, promising Crohn's disease therapeutics, and important regulatory updates affecting clinical practice.
Revolutionary Diagnostic Technology (00:00 - 01:20)
- Atmo Biosciences FDA Clearance: First ingestible gas-sensing capsule for gut motility disorders
- Eliminates need for gastric scintigraphy and radio-opaque marker studies
- Validated in 209-subject pivotal clinical study across 12 sites
- Available July 2025
AI and Spatial Computing in Endoscopy (01:20 - 02:33)
- Cosmo Pharmaceuticals + Apple Vision Pro: First clinical study combining AI endoscopy with spatial computing
- GI Genius AI system integration with Apple Vision Pro headset
- 14.4% increase in adenoma detection rates
- Study begins July 2025 at Rush University Medical Center (Dr. Irving Waxman)
- Fujifilm EC-860P: New slim colonoscope with enhanced imaging capabilities
Clinical Trial Breakthroughs (02:33 - 03:59)
- Tulisokibart for Crohn's Disease: APOLLO-CD trial results
- 50% clinical remission vs. 16% historical controls
- TL1A protein targeting with precision medicine approach
- Geneoscopy ColoSense: Real-world screening performance data
- 14% reduction in CRC deaths vs. FIT testing
- 86% reduction vs. blood-based tests
Regulatory Updates and Quality Concerns (03:59 - 05:38)
- FDA Import Alert - Olympus: Restrictions on Aizu facility devices
- Affects bronchoscopes, laparoscopes, ureterorenoscopes
- Quality system violations and compliance issues
- Nitinotes EndoZip: FDA IDE approval for automated ESG platform
- 184-patient pivotal trial across 10 US sites
Professional Guidelines and Market Consolidation (05:38 - 06:58)
- ACG/WGO H. pylori Guidelines: Updated treatment recommendations
- Emphasis on clarithromycin resistance testing
- AGA Crohn's Disease Guidelines: Public comment period through July 20, 2025
- Torrent-JB Pharmaceuticals: $3.01 billion acquisition
Clinical Implications and Future Outlook (06:58 - 08:22)
- Integration recommendations for clinical practice
- Convergence of AI, spatial computing, and precision medicine
- Future of gastroenterology practice
Published Research
- "Tulisokibart for Crohn's Disease: APOLLO-CD Trial Results"
- The Lancet Gastroenterology & Hepatology
- 50% clinical remission rate in moderate-to-severe Crohn's disease
- Cedars-Sinai study led by Dr. Dermot McGovern
- "ColoSense Real-World Screening Impact Study"
- Clinical Gastroenterology and Hepatology
- 10-year Markov modeling study
- Superior performance vs. FIT and blood-based tests
- "Atmo Biosciences Gas-Sensing Capsule Validation Study"
- Pivotal clinical study: 209 subjects across 12 sites (11 US, 1 Australia)
- FDA 510(k) clearance for gut motility disorders
Clinical Trials in Progress
- Cosmo Pharmaceuticals AI + Apple Vision Pro Study
- Rush University Medical Center
- Principal Investigator: Dr. Irving Waxman
- Study initiation: July 2025
- Nitinotes EndoZip Pivotal Trial
- 184 patients across 10 US sites
- Randomized controlled trial vs. FDA-approved device
- Patient enrollment: Q3 2025
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