Intelligent Bio Solutions Completes Clinical Cut-off Study, Advances FDA 510(k) Clinical Program Targeting Multi-Billion-Dollar U.S. Drug Screening Market
Intelligent Bio Solutions Inc. (INBS)
Company Research
Source: GlobeNewswire
Study results finalized on schedule support FDA clearance and planned U.S. commercial launch Company advances second phase of clinical program for 510(k) submission with method comparison, usability, and interference testing NEW YORK, April 02, 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 successful completion of its initial clinical Cut-off Study supporting the Company's FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine. The clinical Cut-off Study evaluated codeine detection cut-off levels in 40 adults, with full data analysis completed as planned by the end of March 2026. The study used the Intelligent Fingerprinting Drug Screening Cartridge with the DSR-Plus fluorescence reader, compared results with an FDA-cleared predicate d
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News
- Intelligent Bio Solutions Advances Upcoming FDA 510(k) Submission, Successfully Completes Penetration Testing with No Major Vulnerabilities IdentifiedGlobeNewswire
- Intelligent Bio Solutions (INBS) was upgraded by <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=INBS&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street Zen</a> fromMarketBeat
- Intelligent Bio Solutions Strengthens European IP Portfolio with Eighth Patent GrantGlobeNewswire
- Intelligent Bio Solutions Successfully Manufactures and Ships First Readers with New Partner, Accelerating Scale and Driving Gross Margin Expansion in Anticipation of Planned U.S. EntryGlobeNewswire
- Intelligent Bio Solutions Partners with Bouygues UK, Part of Multi-Billion Dollar Global Construction Giant Bouygues Construction, for UK Drug Testing RolloutGlobeNewswire
INBS
Sec Filings
- 3/20/26 - Form 4
- 3/20/26 - Form 4
- 3/20/26 - Form 4
- INBS's page on the SEC website