- Intelligent Bio Solutions (Nasdaq: INBS) advances FDA 510(k) submission with new ultra-precise sweat detection data.
- The company completed successful cybersecurity and electromagnetic compatibility testing to validate system resilience.
- INBS plans to enter the U.S. market in 2025, pending FDA clearance for its opiate test system for codeine.
Intelligent Bio Solutions Inc. (Nasdaq: INBS) has announced significant progress in its FDA 510(k) submission process for the Intelligent Fingerprinting Drug Screening System. The company has revealed new data that highlights the system's capability to detect trace volumes of fingerprint sweat with ultra-precision, using an Ultra-Micro Balance scale capable of measuring down to 0.0000001 grams. This development strengthens the company's position as it seeks regulatory approval.
The technological advances are supported by comprehensive cybersecurity and electromagnetic compatibility testing. These rigorous tests ensure the system's resilience and security, which are increasingly critical factors in the FDA approval process for diagnostic devices. The proactive approach taken by INBS aims to minimize regulatory risks and expedite the approval timeline.
Furthermore, INBS has confirmed that over 6,000 hours have been invested by its R&D team in testing, data aggregation, and technical reporting, which underscores the company's commitment to achieving regulatory clearance. Presently, INBS supports over 450 accounts across 24 countries through 18 distribution partners, showcasing the global reach and existing market validation of its technology.
Looking forward, the company is preparing to enter the U.S. market in 2025, focusing on obtaining FDA clearance specifically for an opiate test system for codeine. This move is part of a broader strategy to tap into the multi-billion dollar U.S. market for non-invasive drug testing solutions, particularly in safety-critical industries where traditional testing methods face increasing challenges.
