Intelligent Bio Solutions Inc. INBS

Management to discuss FDA 510(k) submission, clinical data, and commercial progress outside the U.S.NEW YORK, Sept. 10, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced that it will host a virtual fireside chat on Thursday, September 24, 2026, at 4:30 p.m. ET. The moderated discussion will feature Harry Simeonidis, President and CEO, and Pet

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. The filing focuses on detecting codeine and represents a major push to capture a share of the massive U.S. drug screening market. Extensive Clinical Evidence Drives Application To support the FDA submission, the company completed a multi-stud

Submission package includes Method Comparison Study, which delivered accuracy above 98%, sensitivity above 94%, and 100% specificity across three independent U.S. clinical sitesNEW YORK, Sept. 09, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the submission of its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA

Multi-site clinical study delivers strong performance data for Intelligent Fingerprinting Drug Screening SystemNEW YORK, Sept. 01, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the results of its latest Method Comparison Study for its Intelligent Fingerprinting Drug Screening System (the “System”) to detect the opiate codeine. Conducted a

$5 Million Upfront at Closing and $5 Million Tranche Warrant Callable by the Company Following FDA 510(k) Clearance of Intelligent Fingerprinting Drug Screening SystemNEW YORK, Sept. 01, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (“INBS” or the “Company”) (Nasdaq: INBS), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced that it has entered into a securities purchase agreement with a single existing institutional investor to i

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. 19, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc.

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. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced that its Intelligent Fingerprinting Drug Screening business has been recertified to the ISO 13485:2016 quality m

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. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the completion of its multi-site Method Comparison Study for the Intelligent Fingerprinting Drug Screening System, one of several s

Study confirms the system can be effectively administered by operators with no specialist backgroundNEW YORK, Aug. 05, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the completion of its Usability Study for the Intelligent Fingerprinting Drug Screening System, supporting its FDA 510(k) submission for U.S. market clearance for detection of

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. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the completion of its Interference Study for the Intelligent Fingerprinting Drug Screening System. The study su

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. drug screening market NEW YORK, July 23, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced that it has addresse

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. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the completion of precision testing, a key component of the Company's FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerp

Interference Study designed to validate system specificity in the presence of potentially interfering substances commonly encountered in real-world settings Company expects to complete the study by mid-July 2026, with plans to include results in its FDA 510(k) submission package, along with data from the concurrent Method Comparison Study NEW YORK, June 16, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering in