Merit Medical Systems has signed a $22 million agreement to acquire the C2 CryoBalloon device and related technology from PENTAX of America, expanding its footprint in gastroenterology. The device is used to treat Barrett’s esophagus, gastric antral vascular ectasia (GAVE), GERD-related disorders, and other GI tissue conditions through targeted cryoablation.
Author: Abhay Panchal
The FDA has requested the withdrawal of obeticholic acid (Ocaliva), used to treat primary biliary cholangitis (PBC). Manufacturer Intercept Pharmaceuticals announced the drug will remain available during a 60-day transition period ending Nov. 14, 2025, after which it will no longer be commercially sold in the U.S.
Gastroenterologist Naresh Gunaratnam, MD warns that insurers are undermining colorectal cancer care by mailing unsolicited Cologuard kits directly to patients — often those for whom stool testing is inappropriate. One patient with a prior colectomy endured needless anxiety and procedures after a false positive. Gunaratnam argues this practice confuses patients, bypasses physicians, and contradicts national GI society guidelines.
Eli Lilly’s tirzepatide (Zepbound/Mounjaro) and Novo Nordisk’s semaglutide (Wegovy/Ozempic) are locked in a battle shaping the future of obesity care. Early head-to-head data gives Lilly an edge, but prescribing remains a mix of insurance hurdles, patient complications, and trial-and-error. Oral formulations are on the horizon, with convenience likely to sway patient preference—but efficacy, safety, and coverage remain uncertain. As experts caution, the competition could bring innovation and access—or leave costs and insurance barriers firmly in place.
Immunai has signed an up-to-$85M deal with AstraZeneca to develop a new therapeutic target for inflammatory bowel disease (IBD). The target was discovered using Immunai’s Immunodynamics Engine (IDE), which applies machine learning to single-cell multi-omics data from its immune cell atlas, AMICA. This marks a shift from their oncology-focused work launched in 2022, expanding AstraZeneca’s stake in AI-powered immune mapping. With IDE now integrating 300,000+ patient samples, the partnership could redefine immune-driven drug discovery—potentially accelerating therapies for IBD and beyond.
A new colonoscopy simulator from RZero Inc. (Mikoto™) is showing promise in training future endoscopists. Validated against the UK’s National Endoscopy Database KPIs, the simulator provides real-time feedback on performance and patient comfort, generating a single score (MSS). In trials with 20 endoscopists, MSS strongly correlated with adenoma detection rate, caecal intubation, and comfort scores. Early results suggest Mikoto™ could become a powerful training tool—bridging the gap between simulation and real-world colonoscopy outcomes.
UnitedHealthcare’s new policy slashing CRNA reimbursements by 15% has sparked backlash. The American Gastroenterological Association, joining a coalition led by nurse anesthetists, warns the cut could jeopardize access to cancer screenings and GI procedures—particularly in rural and underserved areas. Effective Oct. 1, anesthesia claims billed under the QZ modifier now receive just 85% of the allowable rate, though a handful of states are exempt. The fight over reimbursement could reshape patient access and practice economics.
Penn Gastroenterology has begun using GI Genius™, the first FDA-approved AI device for colonoscopy, to boost real-time detection of precancerous polyps—particularly in underserved communities in West Philadelphia. Backed by a grant, the program aims to lower colon cancer risk by improving adenoma detection rates (ADR), where Penn already surpasses the national benchmark (38% vs. 26%). Early results show GI Genius™ improves pathology-confirmed findings by 13% over standard colonoscopy. While cost and reimbursement remain challenges, Penn is piloting the technology at no charge to patients, positioning AI as a potential future standard of care in colon cancer prevention.
The government shutdown that began October 1, 2025, is hitting rural and safety-net providers the hardest, with funding lapses adding to already thin margins. While Medicare and Medicaid continue to operate, critical flexibilities — like telehealth and hospital-at-home reimbursements — have lapsed, forcing providers to either absorb costs or warn patients they may be billed. Community health centers, federally qualified health centers, and hospitals reliant on Medicare add-ons are under immediate strain, with some only able to sustain operations for 30 days without new federal funds.
A large Dutch study of over 239,000 individuals in a colorectal cancer (CRC) screening program found that endoscopist performance—measured by adenoma detection rate (ADR) and proximal serrated polyp detection rate (PSPDR)—is more predictive of post-colonoscopy CRC (PCCRC) risk than the presence of high-risk polyps. High-risk polyps (≥10 mm, high-grade dysplasia, or multiple adenomas) did not correlate with higher short-term cancer risk. Instead, each 1% increase in ADR reduced PCCRC risk by 6%, and each 1% increase in PSPDR by 8%. Patients with low-risk polyps but examined by low-performing endoscopists had twice the cancer risk compared to those with high-risk polyps…