Intelligent Bio Solutions resolved all cybersecurity and software review items ahead of a planned FDA 510(k) submission in H2 2026.
Key Highlights:
- Completed independent penetration testing and remediated all cybersecurity review items, reducing regulatory risk.
- 100% of medium-risk vulnerabilities fixed; low-risk issues cut from 11 to 2 with risk-based justifications provided.
- All 19 SBOM vulnerabilities resolved and documentation aligned with FDA guidance; third-party verification found no remaining issues.
- 510(k) package remains on track for calendar H2 2026, targeting codeine detection to enable U.S. market entry beyond forensic use.
- Manufacturing partnership expected to cut production costs >40% and improve gross margin by ~20 percentage points, supporting scalable launch.
Original SEC Filing: INTELLIGENT BIO SOLUTIONS INC. [ INBS ] – 8-K – Jul. 23, 2026
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