USFDAJul 23, 2026, 05:01 PM
Intelligent Bio Solutions Addresses FDA 510(k) Cybersecurity Items
AI Summary
Intelligent Bio Solutions Inc. announced it has addressed all cybersecurity and software-related review items for its upcoming FDA 510(k) submission, following independent third-party penetration testing. This resolution of all vulnerabilities significantly de-risks the submission process. The company remains on track to submit its 510(k) notification in calendar H2 2026, advancing its planned entry into the U.S. drug screening market.
Key Highlights
- Addressed all cybersecurity and software-related review items for upcoming FDA 510(k) submission.
- Completed remediation of all cybersecurity review items, resolving 100% of medium-risk vulnerabilities.
- Reduced low-risk vulnerabilities from 11 to 2, with remaining items risk-justified.
- Resolved all 19 software bill of materials (SBOM) vulnerabilities.
- 510(k) package submission on track for calendar H2 2026.
- Targets codeine detection as the initial indication for clearance.
- Aims for entry into the multi-billion-dollar U.S. drug screening market.
- Manufacturing partnership expected to deliver >40% annual production cost savings and ~20 percentage points gross margin improvement.
Price Impact
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