Intelligent Bio Solutions Inc. provided an updated timeline for anticipated FDA 510(k) clearance for its Intelligent Fingerprinting Drug Screening System, now expected in the second half of the 2026 calendar year. This revised timeline follows recent feedback from the U.S. Food and Drug Administration (FDA).
The company plans to commence new clinical studies before calendar year-end 2025 to gather additional supporting data, which are scheduled to conclude in the first half of 2026. These studies aim to further validate the system and strengthen its new 510(k) submission to the FDA.
Peter Passaris, Vice President of Product Development, stated that the company has a clear and achievable timeline for resubmitting its 510(k) application. While pursuing U.S. clearance, INBS continues to advance its commercial operations outside the U.S., with its drug testing technology adopted by over 450 accounts in 24 countries.
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