Intelligent Bio Solutions Inc. Announces Progress Toward Completion of Clinical Study Plan Required for FDA 510(k) Submission
Intelligent Bio Solutions Inc. (INBS)
Company Research
Source: GlobeNewswire
NEW YORK, Sept. 05, 2024 (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 its progress toward completion of the clinical study plan required for its FDA 510(k) submission. In August 2024, INBS announced its partnership with CenExel to perform the method comparison study as part of the Company’s clinical study plan. The study involves the recruitment of 135 healthy adult subjects across three sites under an IRB-approved protocol and comparing the results of fingerprint sweat opiate screening tests with those obtained using a validated, traceable liquid chromatography-mass spectrometry (LC-MS/MS) method in a laboratory. The Company has successfully completed approximately one-third of the subject enrollment targets for its method comparison study, including screening, consenting, and fingerprint sweat specimen collection acti
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INBS
News
- Intelligent Bio Solutions to Participate in the Noble Capital Markets’ 20th Annual Emerging Growth Equity ConferenceGlobeNewswire
- Intelligent Bio Solutions Announces Positive Results of PK Study, a Key Milestone on Path to FDA 510(k) SubmissionGlobeNewswire
- Intelligent Bio Solutions Reports Fiscal 2025 First Quarter Financial Results and Operational HighlightsGlobeNewswire
- Intelligent Bio Solutions Partners with B2i Digital to Amplify Investor OutreachGlobeNewswire
- Intelligent Bio Solutions Announces Preliminary Unaudited Fiscal 2025 First Quarter Revenue ResultsGlobeNewswire
INBS
Sec Filings
- 11/20/24 - Form 8-K
- 11/14/24 - Form SC
- 11/14/24 - Form SC
- INBS's page on the SEC website