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HHS FDA Establishes Class II Category for Ingestible Gastrointestinal Blood Detection Capsule
June 17, 2026
WASHINGTON, June 17 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has established a Class II regulatory classification for ingestible gastrointestinal blood detection capsules, creating a pathway for devices that detect blood within the digestive tract to enter the market under special controls rather than the more stringent Class III framework.

FDA said the device is a prescription-only capsule that uses spectrophotometry, or light absorpt . . .

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