INTELLIGENT BIO SOLUTIONS INC. 8-K

What Happened
Intelligent Bio Solutions, Inc. (INBS) announced on January 28, 2026 (via an 8-K and attached press release) that it has commenced a clinical study program to support a new FDA 510(k) submission seeking U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine.

Key Details

• Press release dated January 28, 2026 was attached to the 8-K as Exhibit 99.1.
• The clinical study is intended to support a new FDA 510(k) submission for U.S. market clearance.
• The device named: Intelligent Fingerprinting Drug Screening System; target analyte specified: opiate codeine.
• The filing discloses the start of the study but does not provide timelines, results, or financial details.

Why It Matters
A successful 510(k) clearance would enable the company to market its codeine screening system in the U.S., potentially expanding commercial opportunities. For investors, the announcement signals progress on a regulatory pathway for a specific product, but it is an early-stage development: no regulatory outcome, revenue impact, or timetable was provided in the filing. Continue to watch for study results, regulatory filings, and any related commercial or financial updates.