Intelligent Bio Solutions Completes Cybersecurity Review Ahead Of Planned FDA 510(k) Submission

Intelligent Bio Solutions Inc., a medical technology company developing rapid, non-invasive testing solutions, has announced that it has successfully completed all cybersecurity and software-related requirements for its upcoming U.S. Food and Drug Administration (FDA) 510(k) submission. The milestone follows the completion of an independent third-party penetration test and confirms that all previously identified review items have now been addressed. The Company remains on schedule to submit its 510(k) notification during the second half of calendar year 2026.

Earlier in April 2026, Intelligent Bio Solutions reported that independent penetration testing of its system had identified no major cybersecurity vulnerabilities. Since then, the Company has completed the full remediation process, resolving all cybersecurity review items. According to the Company, all medium-risk vulnerabilities have been fully remediated, while the number of low-risk vulnerabilities has been reduced from 11 to just two. The remaining low-risk findings have been supported by a comprehensive risk assessment demonstrating that they do not affect the device's safety, effectiveness, or overall performance.

The Company also reported that all 19 software bill of materials (SBOM) vulnerabilities have been fully resolved. Associated documentation and software configurations have been updated to align with FDA cybersecurity guidance, and an independent third-party review confirmed that no outstanding cybersecurity or software issues remain. Intelligent Bio Solutions believes these achievements significantly reduce regulatory risk and further strengthen its FDA 510(k) submission package ahead of the planned filing later this year.

Harry Simeonidis, President and Chief Executive Officer of Intelligent Bio Solutions, described the completion of the cybersecurity and software review process as an important milestone for the Company. He said that resolving all outstanding issues following independent security testing represents a significant step toward the Company's planned entry into the U.S. market. Simeonidis added that Intelligent Bio Solutions believes it is well positioned to complete the remaining stages of the FDA review process and proceed with its planned 510(k) submission during the second half of 2026.

The Company's initial 510(k) submission will seek clearance for the detection of codeine using its Intelligent Fingerprinting Drug Screening System. If FDA clearance is obtained, the Company expects to expand its commercial opportunities in the United States beyond its current Forensic Use Only applications. According to Intelligent Bio Solutions, the U.S. drug screening market represents a multi-billion-dollar opportunity across workplace drug testing, law enforcement, criminal justice, pain management, and substance abuse treatment programs.

To support future commercialization, the Company has also strengthened its manufacturing capabilities through its partnership with Syrma Johari MedTech. Intelligent Bio Solutions expects the collaboration to reduce annual production costs by more than 40% while improving annual gross margins by approximately 20 percentage points. The Company believes these operational improvements will help support a scalable commercial launch in the United States following potential FDA clearance.

The Intelligent Fingerprinting Drug Screening System is designed to provide a fast, non-invasive alternative to traditional drug testing methods. The system collects fingerprint sweat samples within seconds and delivers results in less than ten minutes at the point of testing. The technology is intended to detect recent drug use within approximately 16 to 24 hours before testing. Outside the United States, the system is already being used commercially across workplace, law enforcement, and government settings to screen for substances including opiates, cocaine, methamphetamine, and cannabis.