Gut Microbiome AI Real-Time Monitoring Patch GutSense Receives CE Certification: Stool Sample Analysis Replaced by Wearable Device for the First Time

Gut Microbiome AI Real-Time Monitoring Patch GutSense Receives CE Certification

On September 15, 2030, German medical device company VivaLytics received EU CE certification for its GutSense gut microbiome monitoring patch. The patch adheres to abdominal skin and assesses gut microbiome status in real time by analyzing volatile organic compounds (VOCs) that penetrate the intestinal wall.

Traditional gut microbiome analysis requires stool sample collection and laboratory gene sequencing, a process taking 3 to 5 days and costing $300 to $500 per test. GutSense uses a built-in array of micro gas chromatography sensors to detect 12 characteristic VOCs produced by the gut, inferring gut flora composition and activity through AI algorithms.

VivaLytics CEO Anna Weber said GutSense's correlation with traditional stool sequencing methods reaches 87%. "It can't tell you how many species of bacteria are in your gut, but it can tell you the overall functional state of your gut — which metabolic pathways are active and which are suppressed. For daily health management, this information is sufficient."

The GutSense patch measures approximately 3x3 centimeters and is 4 millimeters thick, designed for continuous wear for 7 days before replacement. Data syncs via Bluetooth to a smartphone app that provides daily gut health scores and dietary recommendations. A single patch is priced at 49 euros, with a monthly subscription plan at 35 euros.

GutSense has partnered with DAK, Germany's largest health insurance company, to incorporate the patch into management plans for irritable bowel syndrome (IBS) patients.