- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
Intelligent Bio Solutions Inc. sought FDA 510(k) clearance for market expansion.
10 reports, 3 independent
Updated Aug 19
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- Reports
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- Repetition
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New informationRepeats or wire copies
AI-generated analysis. Brind wrote this summary from the reports listed below. It can be wrong. Each section says how much you can rely on it, and the sources are linked so you can check.
What happened
Intelligent Bio Solutions Inc. sought FDA 510(k) clearance for market expansion.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.Seeking FDA 510(k) clearance for market expansion.1 source
Company seeks FDA approval for screening system.1 source
Keep exploring
Part of
A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.Also in this story
- A partnership with BARDA has accelerated the development of SCY-247 for the company.
- A company plans to submit regulatory applications to the FDA, EMA, and Australian TGA.
- Approval leads to procurement process initiation.
- UroGen Pharma Ltd., headquartered in Princeton, is seeking FDA approval for its products for the U.S. market.
The entities involved
Related events
- FDA granted 510(k) clearance for combined technologies for Solventum.
- A company is seeking FDA 510(k) clearance while simultaneously conducting a private placement and qualifying its prospectus in British Columbia.
- The FDA granted 510(k) clearance to SimBioSys's software.
- Providence Medical Technology, Inc. received 510(k) clearance from the FDA and plans to showcase its system at the Henry B. González Convention Center.
- FDA approval is the goal for product candidates from Daré Bioscience, Inc.
Coverage
Newest first; wire copies grouped- manilatimes.net
- manilatimes.net
- GlobeNewswireIntelligent Bio Solutions Reports Fiscal 2025 Fourth Quarter and Full Year Results, Highlighting Progress on Planned U.S. Market Expansion, Revenue Growth and Increased Operational Efficiencies Compa
- BenzingaEXCLUSIVE: Intelligent Bio Expects Double Digit Topline Growth In Q4 Intelligent Bio Solutions Inc. (NASDAQ:INBS) reported preliminary fiscal fourth quarter revenue results and selected operational h
- GlobeNewswireIntelligent Bio Solutions Announces Preliminary Fiscal Fourth Quarter Revenue with Double-Digit Sequential and Year-Over-Year Growth and Strong Operational Momentum Company anticipates fiscal fourth
- GlobeNewswireIntelligent Bio Solutions Strengthens FDA 510(k) Package with New Cybersecurity and Performance Data Ahead of Planned U.S. Market Launch FDA response expected within six weeks; Company remains focuse
- GlobeNewswireIntelligent Bio Solutions Inc. Enters Into Agreements to Raise $3.8 Million in Gross Proceeds Proceeds to Fund Completion of the Company’s 510k Filing with the U.S. FDA for its Fingerprint Drug Scree
- BenzingaEXCLUSIVE: Intelligent Bio Solutions' New Data Confirms Ability To Detect Trace Sweat Volumes At Ultra-Micro Level Intelligent Bio Solutions Inc. (NASDAQ:INBS) on Wednesday announced the collection o
- GlobeNewswireIntelligent Bio Solutions to Strengthen FDA 510(k) Submission with New Positive Data Demonstrating Ultra-Precise Fingerprint Sweat Detection and Platform Resilience Data confirms Company’s ability to