INBS

Latest SEC Filings & News for INBS

5 most recent filings and news items mentioning INBS. Updated every 60 seconds.

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Intelligent Bio Completes Study to Support FDA 510(k) Submission

Intelligent Bio Solutions completed a usability study for its Intelligent Fingerprinting Drug Screening System confirming effective use by non-specialist operators. This milestone aligns with the company's plan to submit a 510(k) in Q3 2026 to enter the U.S. market.

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INBS Completes Interference Study to Support FDA Clearance

Intelligent Bio Solutions has completed an interference study to validate the accuracy of its drug screening system under real-world conditions, solidifying plans to submit the FDA 510(k) package in the second half of 2026 to enter the U.S. market.

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Intelligent Bio Solutions to submit FDA 510(k) in H2 2026

The company resolved all cybersecurity and software review items, de-risking the regulatory path for its fingerprint drug test. The move positions INBS for U.S. market entry into a multi-billion-dollar industry.

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INBS completes 1,600 tests for FDA clearance bid

Intelligent Bio Solutions completed precision testing of its fingerprint drug screen across three sites to support its FDA 510(k) submission for the U.S. opiate detection market, valued at over $1 billion.

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INBS commences multi-site method comparison study for FDA 510(k) submission

Intelligent Bio Solutions initiated a clinical study with CenExel to validate its Intelligent Fingerprinting Drug Screening System for FDA clearance, with enrollment completion expected by July 2026. The study demonstrates real-world usability by non-specialized personnel, a key

View filing at SEC.gov →
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