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Intelligent Bio Solutions | 8-K: Current report

SEC ·  Dec 19, 2024 06:19

Summary by Futu AI

Intelligent Bio Solutions has submitted a 510(k) premarket notification to the FDA for its Intelligent Fingerprinting Drug Screening System on December 18, 2024. The system demonstrated impressive performance with 94.1% accuracy in validation studies and showed fingerprint sweat provides reliable drug detection comparable to blood testing at 95% confidence level.The innovative system offers rapid, non-invasive drug screening through fingerprint sweat analysis, delivering results within 10 minutes. It targets safety-critical industries including construction, transportation, mining, and logistics, while also serving law enforcement and drug rehabilitation sectors. The technology has already proven successful in international markets, delivering cost savings and operational efficiencies.The FDA submission marks a crucial step toward the company's planned US market entry in 2025. As one of the largest drug screening markets globally, US expansion presents significant opportunities for revenue growth and market share acquisition. The system's non-invasive nature and rapid results position it as a potentially disruptive technology in the drug screening industry.
Intelligent Bio Solutions has submitted a 510(k) premarket notification to the FDA for its Intelligent Fingerprinting Drug Screening System on December 18, 2024. The system demonstrated impressive performance with 94.1% accuracy in validation studies and showed fingerprint sweat provides reliable drug detection comparable to blood testing at 95% confidence level.The innovative system offers rapid, non-invasive drug screening through fingerprint sweat analysis, delivering results within 10 minutes. It targets safety-critical industries including construction, transportation, mining, and logistics, while also serving law enforcement and drug rehabilitation sectors. The technology has already proven successful in international markets, delivering cost savings and operational efficiencies.The FDA submission marks a crucial step toward the company's planned US market entry in 2025. As one of the largest drug screening markets globally, US expansion presents significant opportunities for revenue growth and market share acquisition. The system's non-invasive nature and rapid results position it as a potentially disruptive technology in the drug screening industry.

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