Intelligent Bio Solutions Inc. provided an update on its FDA 510(k) clearance process, announcing that the FDA has requested new additional information, requiring the company to resubmit a new 510(k) notification. This follows the FDA's review of INBS's August 2025 submission, which addressed over 70 items from an earlier Additional Information (AI) request.
The FDA's feedback indicates that, as a first-of-its-kind device with no comparable cleared or approved sweat-based product currently on the market, INBS’s Intelligent Fingerprinting Drug Screening System requires extensive supporting information. The company is currently evaluating the FDA’s questions and consulting with specialized FDA consultants.
President and CEO Harry Simeonidis stated that while the FDA’s feedback provides constructive clarity, the company remains fully committed to bringing its innovative solution to the U.S. market. INBS expects to provide an investor update within ten days outlining an updated timeline for FDA clearance, while its international business continues to grow.
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