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The Company is initiating clinical studies to further validate Intelligent Fingerprinting Drug Screening System
INBS anticipates FDA 510(k) clearance in the second half of 2026
NEW YORK, Sept. 26, 2025 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (NASDAQ: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today is providing an update on the timeline for anticipated FDA 510(k) clearance for the use of its Intelligent Fingerprinting Drug Screening System for the opiate codeine.
Following recent feedback from the U.S. Food and Drug Administration (FDA), INBS has established a pathway to gather additional supporting data to strengthen its new 510(k) submission to the FDA. The Company plans to commence clinical studies to further validate its Intelligent Fingerprinting Drug Screening System before calendar year-end. These studies are scheduled to conclude in the first half of the 2026 calendar year. INBS anticipates FDA 510(k) clearance in the second half of the 2026 calendar year.
INBS's drug testing technology has been adopted by over 450 accounts in 24 countries, with 18 distribution partners expanding its global reach. The Company continues to advance its commercial operations outside the U.S., with growing adoption across industries, including construction, transportation, logistics, and mining, while simultaneously working toward FDA clearance for U.S. entry beyond the Forensic Use Only market.
Posted In: INBS
