Intelligent Bio Solutions' FDA clearance process on track for 2025 U.S. launch

INTELLIGENT BIO SOLUTIONS INC.

510(k) submitted Dec 18, 2024; FDA issued Additional Information request, pausing 90-day review clock.
Company responding to AI request; clearance expected within 3–6 months or longer if additional data needed.
System demonstrated 94.1% accuracy in method comparison study; PK data closely aligned to blood at 95% confidence level.
Targeting opiate test system for codeine; full panel already in 19 countries with over 400 accounts.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.