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Intelligent Bio Solutions | 8-K: Current report

Intelligent Bio Solutions | 8-K: Current report

Intelligent Bio Solutions | 8-K:重大事件
美股SEC公告 ·  2024/12/19 06:19

牛牛AI助理已提取核心訊息

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.
智能生物解決方案公司於2024年12月18日向FDA提交了其智能指紋藥物篩查系統的510(k)上市前通知。該系統在驗證研究中表現出94.1%的準確率,並顯示指紋汗水提供的藥物檢測結果可與血液檢測相媲美,置信度達到95%。這一創新系統通過指紋汗水分析提供快速、非侵入性的藥物篩查,結果在10分鐘內交付。它針對安全關鍵行業,包括施工、交通、採礦和物流,同時也服務於執法和藥物康復部門。這項科技在國際市場上已經證明其成功,帶來了成本節約和運營效率的提升。FDA的申請標誌着公司2025年計劃進入美國市場的重要一步。作爲全球最大的藥物篩查市場,美國擴展提供了顯著的營業收入增長和市場份額獲得的機會。該系統的非侵入性特徵和快速的結果使其在藥物篩查行業中可能成爲一種顛覆性科技。
智能生物解決方案公司於2024年12月18日向FDA提交了其智能指紋藥物篩查系統的510(k)上市前通知。該系統在驗證研究中表現出94.1%的準確率,並顯示指紋汗水提供的藥物檢測結果可與血液檢測相媲美,置信度達到95%。這一創新系統通過指紋汗水分析提供快速、非侵入性的藥物篩查,結果在10分鐘內交付。它針對安全關鍵行業,包括施工、交通、採礦和物流,同時也服務於執法和藥物康復部門。這項科技在國際市場上已經證明其成功,帶來了成本節約和運營效率的提升。FDA的申請標誌着公司2025年計劃進入美國市場的重要一步。作爲全球最大的藥物篩查市場,美國擴展提供了顯著的營業收入增長和市場份額獲得的機會。該系統的非侵入性特徵和快速的結果使其在藥物篩查行業中可能成爲一種顛覆性科技。

譯文內容由第三人軟體翻譯。


牛牛AI助手部分由第三方人工智慧模型基於資訊內容自動產生。


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