Core Viewpoint - Intelligent Bio Solutions Inc. is progressing through the FDA 510(k) clearance process for its Intelligent Fingerprinting Drug Screening System, which is a novel non-invasive testing solution [1][2][3]. FDA Clearance Process - The company submitted its 510(k) premarket notification to the FDA in December 2024, and received an Additional Information request in February 2025, which included over 70 items to address [2]. - INBS responded to the FDA's questions and submitted additional information in August 2025, but the FDA has requested further information, necessitating a resubmission of the 510(k) notification [3][4]. - The device is unique as there are no comparable sweat-based products currently on the market, requiring extensive validation to demonstrate its performance [3]. Company Strategy and Market Position - The company is consulting with specialized FDA consultants to evaluate the FDA's questions and plans to provide an investor update within ten days regarding the timeline for FDA clearance [4]. - The CEO expressed confidence in the technology and emphasized the company's commitment to bringing the solution to the U.S. market while continuing to grow its international business [5]. - INBS is developing partnerships and driving sales growth outside the U.S., targeting sectors such as construction, manufacturing, transport, and drug treatment organizations [6]. Product Overview - The Intelligent Fingerprinting Drug Screening System is designed for rapid, non-invasive drug testing through fingerprint sweat analysis, screening for drugs commonly found in workplaces [6]. - The system offers quick sample collection and results in under ten minutes, making it a valuable tool for safety-critical industries [6].