INBS

Intelligent Bio Solutions Inc. (NASDAQ:INBS) announced on Wednesday that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) to secure regulatory clearance for its Intelligent Fingerprinting Drug Screening System.

Multi-site clinical study delivers strong performance data for Intelligent Fingerprinting Drug Screening System Multi-site clinical study delivers strong performance data for Intelligent Fingerprinting Drug Screening System

$5 Million Upfront at Closing and $5 Million Tranche Warrant Callable by the Company Following FDA 510(k) Clearance of Intelligent Fingerprinting Drug Screening System $5 Million Upfront at Closing and $5 Million Tranche Warrant Callable by the Company…

Reader installed base grew 22% year-over-year, driving a 35% increase in total consumable cartridges to over 100,000 units Full year gross profit margin expanded to 48.63%, up 778 basis points year-over-year 502 active customers as of June 30, 2026, reflecting continued commercial momentum across safety-critical industries Company made substantial progress toward FDA clearance and planned market expansion during the year NEW YORK, Aug.

Recertification aligns with the FDA's newly amended Quality Management System Regulation and supports the Company's regulatory strategy as it pursues FDA clearanceNEW YORK, Aug. 17, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc.

All clinical data collection across the Company's FDA 510(k) clinical study program is complete; FDA submission on track for second half of 2026NEW YORK, Aug. 11, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc.

Study confirms the system can be effectively administered by operators with no specialist backgroundNEW YORK, Aug. 05, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc.

The Company remains on track to submit its 510(k) package in calendar H2 2026, working toward planned entry into the multi-billion-dollar U.S. drug screening marketNEW YORK, Aug. 03, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc.

Company has addressed final review items from penetration testing and finalized cybersecurity and software documentation 510(k) package submission on track for calendar H2 2026, targeting planned entry into multi-billion-dollar U.S.

Precision testing confirms reproducibility across more than 1,600 tests, three production runs, and three independent testing sitesNEW YORK, July 21, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc.