The U.S. Food and Drug Administration has issued a medical device early alert for certain lots of AXIOS Stent and Electrocautery-Enhanced Delivery System manufactured by Boston Scientific, following reports of deployment failures that may result in serious injury, procedural complications, or death. The affected devices are used in therapeutic endoscopy for transgastric or transduodenal drainage of pancreatic fluid collections (including pseudocysts and walled-off necrosis) and, in select high-risk patients, for gallbladder drainage in acute cholecystitis. According to the FDA, the issue occurs during stent delivery and deployment, when the device may fail to expand or deploy as intended. Successfully implanted…
Author: Abhay Panchal
Salvo Health has raised $8.5 million in Series A funding to accelerate its hybrid, AI-enhanced care model designed to support gastrointestinal and metabolic care delivery through existing GI practices. The round was led by ManchesterStory, City Light Capital, and Threshold Ventures, with participation from new and existing investors including The Artemis Fund, Torch Capital, Felicis Ventures, and others. The raise brings Salvo’s total equity funding to $21.6 million. Salvo positions itself as an enablement layer for GI providers, offering a wraparound, continuous-care platform that integrates registered dietitians, behavioral health professionals, nurses, and AI-driven workflows—without replacing the physician or requiring practices…
Guardant Health has received U.S. Food and Drug Administration approval for Guardant360 CDx as a companion diagnostic to identify patients with BRAF V600E–mutant metastatic colorectal cancer (mCRC) who may benefit from treatment with BRAFTOVI (encorafenib) in combination with cetuximab and chemotherapy. The accelerated approval is supported by data from BREAKWATER trial, which demonstrated improved objective response rate, progression-free survival, and overall survival with encorafenib-based regimens compared with standard care in previously untreated BRAF-mutant mCRC. The findings reinforce the importance of early genomic testing in this aggressive colorectal cancer subtype. Guardant360 CDx enables non-invasive, blood-based detection of BRAF V600E mutations, helping…
Colorectal cancer is on the rise among young people. Now it is the leading cause of cancer death in the U.S. for those under 50, according to a new analysis. More than 1.2 million people under age 50 died of cancer in the U.S. from 1990 through 2023, American Cancer Society researchers reported Thursday. Some 3,905 people ages 20 to 49 died of colorectal cancer in 2023, according to Cancer Society statistics, compared with 3,809 for breast cancer and 2,086 for brain and other nervous system cancers.
A new national analysis examining Medicare reimbursements for the top 10 GI procedures finds a sharp, long-term decline in physician payments—raising concerns about future access to gastroenterology care as the U.S. population ages. Between 2003 and 2023, inflation-adjusted Medicare physician reimbursements in facility settings fell by nearly 46% nationwide, with declines observed across all regions. While the Northeast and West consistently received higher reimbursements, the South and Midwest saw persistently lower payments despite differing levels of GI physician supply. The study highlights several paradoxes: Overall, associations between reimbursement, physician supply, and demand were observed, but these relationships were inconsistent and…
A new analysis from the randomized phase 2 Prevent Anal Cancer (PAC) Self-Swab Study, published in JAMA Network Open, suggests that home-based self-sampling for anal cancer screening can significantly improve participation among high-risk individuals and may be cost-effective from a societal perspective. Participants who self-collected samples at home had higher screening rates than those screened in clinics (89% vs. 74%). While self-sampling incurred higher direct healthcare costs, it reduced indirect burdens such as travel, time, and productivity loss—resulting in a lower incremental cost-effectiveness ratio (ICER) when viewed from a societal lens (~$25 per additional person screened). The study focused on…
Most colorectal cancer (CRC) screening tests, including fecal immunochemical (FIT) and multitarget stool DNA tests, require patients to scrape a stool sample at home before mailing it to a central lab. This requirement not only deters screening adherence but can also introduce risks of human error, environmental exposure, and transit-related issues. The multitarget stool RNA test (mt-sRNA), which comprises a FIT component and an RNA molecular component, is the only FDA-approved stool-based test for the detection of both CRC and advanced adenomas (AA) that does not require patients to perform an at-home FIT. Instead, trained technicians complete the FIT in…
Guardant Health has announced a multi-year global strategic collaboration with Merck (known as MSD outside the US and Canada) to support the development and commercialization of Merck’s oncology pipeline using Guardant’s Infinity™ Smart platform. Under the agreement, Guardant’s liquid and tissue biopsy portfolio will be used as clinical trial enrollment assays across Merck’s global oncology studies. The collaboration also includes joint efforts to develop companion diagnostics to support regulatory approvals and to co-commercialize
In this Medscape Gut Instincts commentary, Alicia H. Muratore, MD, MBA, challenges the traditional, procedure-centric identity of gastroenterology and calls for a broader, more future-ready vision of the specialty. Tracing GI’s roots back to holistic digestion, nutrition, and physiology—long before endoscopy—she argues that the next decade will once again redefine what it means to be a gastroenterologist. Emerging forces such as artificial intelligence, liquid-based cancer screening, digital health, microbiome science, and remote care may significantly reduce reliance on traditional scoping while expanding GI’s clinical influence.
In this episode of The Scope Forward Show, Praveen Suthrum speaks with Alex Noumidis, Co-founder and CEO of Nerva, a digital therapeutic platform for IBS (Irritable Bowel Syndrome) and other disorders of gut-brain interaction. They discuss the origins of Nerva, the science of psychophysiology, digital health adoption in GI, and the challenges of bringing behavioral therapies into mainstream gastroenterology. The conversation dives deep into the power of gut-directed hypnotherapy, its clinical validation, the bottlenecks in scaling access to GI psychology, and what it takes to build a product that patients actually use. They’ve seen 300,000 patients and plan to expand to all…