The team at
@b2idigital is pleased to share an important milestone update from Featured Company,
@ibs_inc_ (Nasdaq: INBS) (
b2idigital.com/intelligent-bβ¦). INBS announced that it has submitted its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its innovative fingerprint sweat-based drug screening technology, marking a critical step toward U.S. market entry.
Highlights from the announcement include:
β’ Validated Performance: The submission includes data demonstrating 94.1% accuracy and PK data closely aligned to blood.
β’ Strategic Expansion: This milestone supports INBSβ plans to expand into the U.S., one of the largest global markets for drug screening.
β’ Broad Market Potential: The systemβs non-invasive, rapid testing method has diverse applications across safety-critical industries, law enforcement, drug rehabilitation and forensics.
Harry Simeonidis, CEO of Intelligent Bio Solutions, commented: βThe submission of our 510(k) application to the FDA is an impactful moment for all of us at Intelligent Bio Solutions, who have worked with perseverance and an intense focus to deliver our 510(k) package on time. Our team showed agility and resourcefulness, working with our clinical research partners to execute our clinical study plan and analyze the data. We are excited about our planned entry into the U.S. market, the opportunities for growth, and the transformational impact that we believe we will have in the drug screening market with our innovative technology.β
For more information, visit the full release at:
ibs.inc/2024/12/18/inbs-annoβ¦
Intelligent Bio Solutions is a medical technology company delivering innovative, rapid, non-invasive testing solutions for employers in safety-critical industries. The companyβs portable, cost-effective drug screening system identifies recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis.
Led by CEO Harry Simeonidis and CFO Spiro Sakiris, Intelligent Bio Solutions continues to push boundaries in non-invasive testing technologies. The companyβs talented global team includes Anna Turkington, Ghanshyam Poudel, Taylor Doherty, Daniel Brown, Doug Heath, Sugam Pokharel, Victoria Gavrilenko, Rafael da Luz, MBA, Callistus Sequeria, Derek Mapoli, and Peter Passaris.
For investor-related questions about INBS, please visit
investors.ibs.inc or contact the companyβs IR contact, Valter Pinto, at INBS@kcsa.com.
#IntelligentBioSolutions #FDA510k #InnovationInTesting #DrugScreening #B2iDigital #INBS