Intelligent Bio Solutions Initiates Additional Clinical Studies for FDA 510(k) Submission Supporting Planned Entry into Multi-Billion Dollar U.S. Market
Intelligent Bio Solutions Inc. (INBS)
Company Research
Source: GlobeNewswire
Clinical studies designed to support FDA clearance and planned commercial launch into the world’s largest drug screening market Company anticipates full data analysis by the end of March 2026; data to be incorporated into FDA 510(k) submission package NEW YORK, Jan. 28, 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 commencement of its clinical study program to support its new FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine. As part of its clinical study program, the Company has again partnered with Cliantha Research, a leading clinical research organization, leveraging its extensive regulatory and clinical trial expertise. The first clinical study will assess codeine detection cut-off levels in 40 adults at a single site. The
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INBS
News
- Intelligent Bio Solutions Expects to Report Fiscal Second Quarter 2026 Revenue Growth of Approximately 48% Year-Over-Year, Surpassing $2 Million in Total Revenue for First Half of Fiscal YearGlobeNewswire
- Intelligent Bio Solutions (NASDAQ:INBS) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=INBS&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">WallMarketBeat
- Intelligent Bio Solutions (NASDAQ:INBS) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Intelligent Bio Solutions Announces Closing of $10.0 Million Private Placement Priced At-the-Market Under Nasdaq RulesGlobeNewswire
- Intelligent Bio Solutions Announces $10.0 Million Private Placement Priced At-the-Market Under Nasdaq RulesGlobeNewswire
INBS
Sec Filings
- 2/5/26 - Form 8-K
- 1/28/26 - Form 8-K
- 1/22/26 - Form EFFECT
- INBS's page on the SEC website