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BriefMEDTECH

Real-Time Gut Microbiome Monitoring Capsule GutSense Passes Clinical Validation: Complete Gut Flora Map Within 24 Hours of Swallowing

Israeli medical device company Check-Caps GutSense smart capsule passes clinical validation. After swallowing, the capsule travels through the digestive tract, detecting gut microbiome composition, pH, and metabolite concentrations in real time, syncing data to a smartphone app.

Israeli medical device company Check-Caps GutSense smart capsule has completed Phase III clinical validation. Measuring 11mm by 26mm, the capsule contains a miniature spectrometer, pH electrode, and rapid 16S rRNA detection module. After swallowing, the capsule travels naturally through the digestive tract.

GutSense collects data every 30 seconds, including rapid DNA fingerprints of local microbiome composition, pH, bile acid concentration, and short-chain fatty acid levels. Data transmits via Bluetooth to an external receiver and syncs to a smartphone app. The entire process takes approximately 18 to 24 hours.

In clinical trials involving 1,200 subjects, GutSense achieved 88% sensitivity in early identification of inflammatory bowel disease and 93% accuracy in classifying gut microbiome dysbiosis. The capsule is single-use, priced at approximately $450, and has received FDA 510(k) clearance.