Intelligent Bio Solutions Inc. Addresses Cybersecurity Items for FDA 510(k)

What Happened

• On July 23, 2026 Intelligent Bio Solutions Inc. (INBS) issued a press release and filed a Form 8‑K (Item 7.01, Regulation FD Disclosure) announcing that it has addressed all cybersecurity and software‑related review items for its upcoming FDA 510(k) submission. The press release is furnished as Exhibit 99.1 to the Form 8‑K.

Key Details

• Filing date and disclosure: Form 8‑K filed July 23, 2026 (Regulation FD Disclosure, Item 7.01).
• Milestone reported: “Addressed all the cybersecurity and software‑related review items” for the planned FDA 510(k).
• Exhibit: Press release dated July 23, 2026 furnished as Exhibit 99.1.
• The filing does not specify a target 510(k) submission date or an FDA review/clearance timeline.

Why It Matters

• Clearing cybersecurity and software review items is a concrete regulatory milestone on the path to a 510(k) submission; it can reduce regulatory risk related to software and device security. For investors, this update signals progress toward regulatory clearance and potential commercialization, but it is not a submission or clearance notice—no filing date or FDA decision timeline was provided.