Intelligent Bio Solutions provides update on FDA 510k clearance process

Intelligent Bio Solutions (INBS) provided an update on its FDA 510(k) clearance process for its Intelligent Fingerprinting Drug Screening System. The FDA appeared to be satisfied with the majority of responses to the items and has responded with a request for new additional information that requires the Company to resubmit a new 510(k) notification. As a first-of-its-kind device with no comparable cleared or approved sweat-based product currently on the market, the Company’s Intelligent Fingerprinting Drug Screening System requires extensive supporting information to validate its performance. The practical feedback received from the FDA is not uncommon for breakthrough technologies