Intelligent Bio Solutions Partners With Cliantha Research To Conduct Clinical Study As Part OOf FDA 510(k) Pathway
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Intelligent Bio Solutions Inc. (INBS) partners with Cliantha Research for a pharmacokinetic study as part of its FDA 510(k) clinical study plan. The study aims to compare opiate levels in fingerprint sweat against traditional specimens, using INBS' Intelligent Fingerprinting Drug Screening System. This marks a significant step in INBS' journey towards FDA approval and U.S. market entry. The FDA has provisionally classified the screening cartridge as a Class II device, requiring 510(k) submission and clearance. The study, starting in May 2024, seeks to validate fingerprint sweat as a reliable testing method for opiates.
February 28, 2024 | 1:35 pm
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Intelligent Bio Solutions Inc. embarks on a crucial pharmacokinetic study with Cliantha Research, aiming for FDA 510(k) approval with its innovative drug screening system. This partnership and study are pivotal for INBS' U.S. market entry plans.
The partnership with Cliantha Research and the initiation of the pharmacokinetic study are significant developments for INBS, indicating progress in its FDA 510(k) approval process. This study is critical for demonstrating the efficacy of INBS' drug screening system, potentially leading to FDA clearance and U.S. market entry. Given the strategic importance of FDA approval for medical technology companies, this news is likely to be viewed positively by investors, potentially leading to a short-term uptick in INBS' stock price.
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