Sep. 29 at 9:43 PM
Intelligent Bio Solutions Inc. (NASDAQ:
$INBS) provided an updated timeline toward anticipated FDA 510(k) clearance for the use of its Intelligent Fingerprinting Drug Screening System for the opiate codeine.
Intelligent Bio Solutions is a B2i Digital Featured company. View INBS’s comprehensive profile at https://b2idigital.com/intelligent-bio-solutions.
Following recent feedback from the U.S. Food and Drug Administration (FDA), INBS has established a pathway to gather additional supporting data to strengthen its new 510(k) submission.
The company announced several developments:
• Clinical studies will begin before year-end to further validate the drug screening system, with completion expected in H1 2026
• FDA 510(k) clearance is anticipated in the second half of 2026
• The technology has achieved strong international traction with over 450 accounts across 24 countries and 18 distribution partners
• Commercial operations continue to expand outside the U.S., while the company works toward U.S. entry beyond the Forensic Use Only market
Peter Passaris, Vice President of Product Development at Intelligent Bio Solutions, noted: “We have a clear and achievable timeline for resubmitting our 510(k) application. The additional clinical data we are generating will supplement existing data and strengthen our package. We are committed to bringing our innovative technology to the U.S. market, while continuing to focus on the growth of the overall business.”
The Intelligent Fingerprinting Drug Screening System screens for opiates, cocaine, methamphetamine, and cannabis through fingerprint sweat analysis, with sample collection in seconds and results in under ten minutes. Current international customer segments include construction, manufacturing and engineering, transport and logistics firms, mining, drug treatment organizations, and coroners.
See the full release at: https://investors.ibs.inc/news/news-details/2025/Intelligent-Bio-Solutions-Advances-Preparations-and-Provides-Updated-Timeline-for-Anticipated-FDA-510k-Submission-and-Clearance/default.aspx.
Led by CEO Harry Simeonidis and CFO Spiro Sakiris, INBS is advancing hygienic, rapid, and cost-effective fingerprint sweat-based testing worldwide. The company’s non-invasive, patented technology delivers results in under ten minutes and now supports more than 450 accounts across 24 countries in the workplace safety, law enforcement, drug treatment, and forensics markets. Its experienced global management team includes Anna Turkington, Ghanshyam Poudel, Taylor Doherty, Daniel Brown, Doug Heath, Sugam Pokharel, Victoria Gavrilenko, Rafael da Luz, MBA, Callistus Sequeira, Derek Mapoli MBus, and Peter Passaris.
For investor inquiries, visit https://investors.ibs.inc or contact Valter Pinto at
[email protected], KCSA Strategic Communications.
Disclosure: David Shapiro, CEO of B2i Digital, personally purchased in the open market and currently owns shares of unrestricted INBS stock, in line with B2i Digital’s practice of investing alongside its Featured Companies. This post is not intended to solicit the sale of INBS or any security, and it is not intended to offer any opinion on INBS as an investment. Conduct your own research and consult with your own professional advisors prior to making any investment decisions. See the complete Disclosure in the Risks and Disclosures section of https://b2idigital.com/disclaimer.