Intelligent Bio Solutions Provides Update on FDA 510(k) Clearance Process for Intelligent Fingerprinting Drug Screening System
Intelligent Bio Solutions Inc. (INBS)
Company Research
Source: GlobeNewswire
NEW YORK, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today provided an update on its FDA 510(k) clearance process for its Intelligent Fingerprinting Drug Screening System. In December 2024, INBS submitted its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for review and clearance of its Intelligent Fingerprinting Drug Screening System. As expected, the FDA reviewed and responded with questions by issuing an Additional Information (AI) request in February 2025. This AI request consisted of over 70 items to be addressed by the Company. With the support of specialized FDA consultants and expert third-party partners, INBS responded to the FDA’s questions and submitted additional information in August 2025. The FDA appeared to be satisfied with the majority of responses to the items and has responde
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News
- Intelligent Bio Solutions to Participate in Noble Capital Markets’ 21st Annual Emerging Growth Equity Conference on December 2-3, 2025GlobeNewswire
- Intelligent Bio Solutions Reports Fiscal 2026 First Quarter Financial Results and Operational Highlights, Delivering Record Revenue GrowthGlobeNewswire
- Intelligent Bio Solutions Expects to Report Record Fiscal First Quarter 2026 Revenue of Over $1 Million, an Increase of Approximately 32% Sequentially and 28% Year-Over-YearGlobeNewswire
- Intelligent Bio Solutions Secures 33 New Customer Accounts in the Fiscal 2026 First Quarter, Showing Strong Year-Over-Year Growth and Increasing Total Active Accounts to 480GlobeNewswire
- Intelligent Bio Solutions Secures Major UK Contract with Multinational Industrial Service ProviderGlobeNewswire
INBS
Sec Filings
- 12/5/25 - Form S-8
- 12/2/25 - Form 8-K
- 11/28/25 - Form 8-K
- INBS's page on the SEC website