Intelligent Bio Solutions must resubmit FDA 510(k) for drug screening system after new info request

INTELLIGENT BIO SOLUTIONS INC.

• FDA requested new additional information in a letter dated September 12, 2025, requiring a new 510(k) resubmission.
• Company previously responded to a February 2025 AI request covering over 70 items and submitted additional data in August 2025.
• First-of-its-kind sweat-based device; FDA feedback described as not uncommon for breakthrough technologies.
• Company expects an investor update within ten days outlining a revised timeline for FDA clearance.
• International commercial activities continue to grow outside the U.S. while pursuing clearance.