
- Intelligent Bio Solutions remains on track for a 2025 U.S. launch of its non-invasive Intelligent Fingerprinting Drug Screening System.
- The company’s FDA 510(k) submission included validation studies showing 94.1% accuracy in detecting opiates through fingerprint sweat.
- INBS is already active in 24 countries, with over 450 commercial accounts globally, and adoption growing across diverse industries, including logistics, mining, retail, and marine operations.
- The firm is expanding its distributor network to support localized growth ahead of its U.S. market entry.
Intelligent Bio Solutions (NASDAQ: INBS), a medical technology company specializing in rapid, non-invasive testing solutions, is preparing for its expected U.S. launch in 2025, as it is progressing through the FDA clearance process for its Intelligent Fingerprinting Drug Screening System. The non-invasive device, which detects recent drug use via fingerprint sweat, is gaining international traction for its speed, portability, and ability to integrate into a range of safety-critical environments.
On Dec. 18, 2024, INBS submitted a 510(k) premarket notification to the U.S. Food and Drug Administration, seeking clearance for its opiate test system for codeine (https://ibn.fm/YVRNE). The FDA classified the system as a Class II medical device, which requires this form of submission. As of March…
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