Camera pills were never quite like this. Developed by Vibrant Gastro Inc. for people suffering from chronic idiopathic constipation (CIC) the Vibrant system capsule is designed to travel deep into the gut and vibrate, augmenting the natural mechanisms of the body that govern bowel function.
Xbiome Inc. acquired M-201, a clinical-stage program from Assembly Biosciences Inc., to treat patients with mild to moderate ulcerative colitis as it looks to develop products to address the growing incidence of bowel disease throughout Asia. The company expects to start a phase Ib trial of the oral live biotherapeutic product in the U.S. in 2022 and also plans to run clinical trials in China.
A 2,000-patient U.K. study has been set up to generate real-world evidence of the value of using AI technology to detect bowel polyps (adenomas) during colonoscopy procedures. The aim is to show whether Medtronic plc’s GI Genius system improves the detection of polyps when deployed in both expert centers and non-specialist units, in the routine diagnostic screening of patients referred from primary care or through the national fecal immunochemical testing program.
Shenzhen Xzing Technology Co. Ltd.’s Endofresh disposable upper gastrointestinal (GI) endoscope has granted the NMPA’s class II approval. The company said the approved product is used for upper gastrointestinal GI endoscopy, diagnosis and treatment.
The FDA granted 510(k) clearance to Metame Health Inc.’s Regulora, the company’s prescription digital therapeutic (PDT) for abdominal pain associated with irritable bowel syndrome (IBS). Regulora provides gut-directed hypnotherapy in a smartphone app that is designed to help patients better manage their symptoms and address miscommunication between the brain and gut that contributes to sensations of pain.
The FDA has granted a breakthrough device designation for Renovia Inc.’s digital therapeutic system Leva as a first-line treatment for chronic fecal incontinence (FI) in women. Fecal incontinence, also known as bowel leakage, is a progressive condition ranging from occasional leaks to a complete loss of bowel control. Common causes include diarrhea, constipation, and muscle or nerve damage that may be associated with aging or giving birth.
PARIS – Mauna Kea Technologies SA reported the commercial launch of a new generation of its in vivo cellular imaging for diagnostics in gastroenterology. At the same time, the company is deploying its new needle-based and miniprobe-based multidisciplinary confocal laser endomicroscopy platform in the U.S., as well as in France, Germany and Italy.
Smart Medical Systems Ltd. has released positive data showing its FDA-cleared G-eye balloon endoscope has a higher adenoma detection rate (ADR) compared to Olympus’ Endocuff Vision (ECV) technology in patients undergoing screening or surveillance colonoscopy.
Castle Biosciences Inc. is acquiring gastrointestinal (GI) diagnostics company Cernostics Inc. in a transaction valued up to $80 million. The deal marks a move from Castle’s focus on dermatology diagnostics to include GI disorders and could expand its estimated U.S. total addressable market by approximately $1 billion, the company said. Shares of Castle Biosciences (NASDAQ:CSTL) jumped 7.8% to close at $67.58 on Tuesday Oct. 19.
Calpro AS and Ampersand Health Ltd. are combining technologies to provide a self-management and remote monitoring solution for people with inflammatory bowel disease (IBD). The partnership will integrate Oslo, Norway-based Calpro’s smart biomarker test with Ampersand’s digital therapeutic app My IBD Care. The companies said the collaboration could help reduce the administrative burden of IBD patient care.