Intelligent Bio Solutions resolves cybersecurity, software items ahead of planned FDA 510(k) filing in H2 2026

Intelligent Bio Solutions said it resolved all cybersecurity and software review items for its planned FDA 510(k) filing.

• The 510(k) submission remains on track for calendar H2 2026, supporting a planned entry into the U.S. drug screening market.
• Penetration-test remediation cleared 100% of medium-risk issues; low-risk items fell to 2 from 11 with a risk-based justification.
• All 19 software bill of materials vulnerabilities were resolved; independent third-party verification found no remaining issues.
• The initial 510(k) indication targets codeine detection, positioning the fingerprint-sweat system for broader U.S. use beyond forensic-only settings.