Intelligent Bio Solutions submitted a 510(k) premarket notification to the U.S. Food and Drug Administration on September 9, 2026, seeking regulatory clearance for its Intelligent Fingerprinting Drug Screening System to detect codeine. The submission includes clinical data from over 18,000 hours of testing across three independent sites, demonstrating accuracy above 98%, sensitivity above 94%, and 100% specificity. The company operates in the medical technology industry, providing rapid, non-invasive drug screening solutions.

Intelligent Bio Solutions Inc. closed a private placement on September 2, 2026, issuing 2,036,659 shares and associated warrants to a single institutional investor for approximately $5.0 million in gross proceeds. The transaction includes Series N-1 and Series N-2 warrants exercisable at $2.33 per share, with the N-1 warrants callable upon FDA 510(k) clearance of its drug screening system. Proceeds are designated for working capital and general corporate purposes. Intelligent Bio Solutions Inc. operates in the medical technology industry, developing non-invasive testing solutions such as fingerprint-based drug screening systems.

Intelligent Bio Solutions Inc. reported full-year fiscal 2026 results ending June 30, 2026, with total revenue of $4.2 million, a 38% year-over-year increase driven by a 22% expansion in its reader installed base to 1,886 units and a 35% rise in consumable cartridge sales to over 100,000 units. Gross profit grew 64% to $2.05 million, expanding gross margin by 778 basis points to 48.63%, supported by a manufacturing transition to Syrma Johari and an optimized product mix. The company reached 502 active customers and completed clinical data collection for its FDA 510(k) submission, targeting U.S. market entry in the second half of calendar 2026. Intelligent Bio Solutions Inc. operates in the medical technology industry, providing intelligent, rapid, non-invasive drug screening solutions via fingerprint sweat analysis.