Intelligent Bio Solutions Submits Key FDA Information

Intelligent Bio Solutions ( (INBS) ) has shared an announcement.

On August 6, 2025, Intelligent Bio Solutions Inc. announced the submission of additional information to the FDA as part of its 510(k) clearance process, aiming for U.S. market entry later in the year. The submission includes extensive cybersecurity and performance data, reinforcing the company’s fingerprint sweat-based drug screening technology. This move is a critical step in the company’s U.S. expansion strategy, with the potential to significantly impact its market presence and commercial opportunities in the multi-billion-dollar U.S. market. The company expects a response from the FDA within six weeks.

Spark’s Take on INBS Stock

According to Spark, TipRanks’ AI Analyst, INBS is a Neutral.

Intelligent Bio Solutions scored moderately due to strong corporate events indicating strategic growth and market expansion. However, persistent financial challenges with negative earnings, cash flow issues, and bearish technical indicators weigh heavily on the overall score. The absence of earnings call data means it could not influence the result.

To see Spark’s full report on INBS stock, click here.

More about Intelligent Bio Solutions

Intelligent Bio Solutions Inc. is a medical technology company specializing in intelligent, rapid, non-invasive testing solutions. The company is known for its Intelligent Fingerprinting Drug Screening System, which utilizes fingerprint sweat analysis to detect recent drug use. This technology is designed to be hygienic and cost-effective, providing results in under ten minutes, and is primarily used in safety-critical industries such as construction, manufacturing, transport, and logistics.

Average Trading Volume: 188,045

Technical Sentiment Signal: Strong Sell

Current Market Cap: $11.15M

For detailed information about INBS stock, go to TipRanks’ Stock Analysis page.