10/07/2025 | Press release | Distributed by Public on 10/07/2025 18:15
In December 2024, INBS submitted its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for review and clearance of its Intelligent Fingerprinting Drug Screening System. As expected, the FDA reviewed and responded with questions by issuing an Additional Information (AI) request in February 2025. This AI request consisted of over 70 items to be addressed by the Company. With the support of specialized FDA consultants and expert third-party partners, INBS responded to the FDA's questions and submitted additional information in August 2025