Intelligent Bio Solutions to Strengthen FDA 510(k) Submission with New Positive Data Demonstrating Ultra-Precise Fingerprint Sweat Detection and Platform Resilience
Intelligent Bio Solutions (Nasdaq: INBS) announced new data strengthening its FDA 510(k) submission for its Intelligent Fingerprinting Drug Screening System. The company completed extensive cybersecurity and electromagnetic compatibility testing to validate system resilience. Using an Ultra-Micro Balance scale capable of measuring 0.0000001 grams, INBS confirmed its technology's ability to detect and analyze trace levels of fingerprint sweat.
The R&D team has invested over 6,000 hours into testing, data aggregation, analysis, and technical reporting. INBS currently supports more than 450 accounts across 24 countries with 18 distribution partners. The company plans to enter the U.S. market in 2025, pursuing FDA clearance for its opiate test system for codeine.
Intelligent Bio Solutions (Nasdaq: INBS) ha annunciato nuovi dati che rafforzano la sua richiesta di autorizzazione FDA 510(k) per il sistema di screening dei farmaci Intelligent Fingerprinting. L'azienda ha completato approfonditi test di cybersecurity e compatibilità elettromagnetica per confermare la resilienza del sistema. Utilizzando una bilancia Ultra-Micro Balance in grado di misurare fino a 0,0000001 grammi, INBS ha verificato la capacità della sua tecnologia di rilevare e analizzare tracce di sudore dalle impronte digitali.
Il team di ricerca e sviluppo ha dedicato oltre 6.000 ore a test, raccolta dati, analisi e redazione di report tecnici. INBS supporta attualmente più di 450 clienti in 24 paesi tramite 18 partner distributivi. L’azienda prevede di entrare nel mercato statunitense nel 2025, puntando all’approvazione FDA per il suo sistema di test degli oppiacei specifico per la codeina.
Intelligent Bio Solutions (Nasdaq: INBS) anunció nuevos datos que fortalecen su solicitud FDA 510(k) para su Sistema de Detección de Drogas Intelligent Fingerprinting. La compañía completó extensas pruebas de ciberseguridad y compatibilidad electromagnética para validar la resistencia del sistema. Utilizando una balanza Ultra-Micro Balance capaz de medir 0.0000001 gramos, INBS confirmó la capacidad de su tecnología para detectar y analizar niveles traza de sudor en las huellas dactilares.
El equipo de I+D ha invertido más de 6,000 horas en pruebas, recopilación de datos, análisis e informes técnicos. Actualmente, INBS respalda a más de 450 cuentas en 24 países con 18 socios de distribución. La compañía planea ingresar al mercado estadounidense en 2025, buscando la aprobación de la FDA para su sistema de prueba de opiáceos para codeína.
Intelligent Bio Solutions (나스닥: INBS)는 Intelligent Fingerprinting 약물 검사 시스템에 대한 FDA 510(k) 제출을 강화하는 새로운 데이터를 발표했습니다. 회사는 시스템의 내구성을 검증하기 위해 광범위한 사이버 보안 및 전자기 적합성 테스트를 완료했습니다. 0.0000001그램까지 측정 가능한 Ultra-Micro Balance 저울을 사용하여 INBS는 지문 땀의 미량을 감지하고 분석하는 기술의 능력을 확인했습니다.
연구개발팀은 테스트, 데이터 집계, 분석 및 기술 보고서 작성에 6,000시간 이상을 투자했습니다. INBS는 현재 18개의 유통 파트너와 함께 24개국에서 450개 이상의 계정을 지원하고 있습니다. 회사는 2025년에 미국 시장에 진입하여 코데인에 대한 아편류 검사 시스템의 FDA 승인을 추진할 계획입니다.
Intelligent Bio Solutions (Nasdaq : INBS) a annoncé de nouvelles données renforçant sa soumission FDA 510(k) pour son système de dépistage des drogues Intelligent Fingerprinting. La société a réalisé des tests approfondis de cybersécurité et de compatibilité électromagnétique afin de valider la résilience du système. En utilisant une balance Ultra-Micro capable de mesurer 0,0000001 gramme, INBS a confirmé la capacité de sa technologie à détecter et analyser des traces de sueur sur les empreintes digitales.
L'équipe R&D a investi plus de 6 000 heures dans les tests, l'agrégation des données, l'analyse et la rédaction de rapports techniques. INBS soutient actuellement plus de 450 comptes dans 24 pays avec 18 partenaires de distribution. La société prévoit d'entrer sur le marché américain en 2025, en visant l'autorisation FDA pour son système de test des opiacés pour la codéine.
Intelligent Bio Solutions (Nasdaq: INBS) gab neue Daten bekannt, die seine FDA 510(k)-Einreichung für das Intelligent Fingerprinting Drug Screening System stärken. Das Unternehmen führte umfangreiche Tests zur Cybersicherheit und elektromagnetischen Verträglichkeit durch, um die Systemresilienz zu validieren. Mit einer Ultra-Micro Balance-Waage, die 0,0000001 Gramm messen kann, bestätigte INBS die Fähigkeit seiner Technologie, Spuren von Fingerabdruckschweiß zu erkennen und zu analysieren.
Das F&E-Team investierte über 6.000 Stunden in Tests, Datenerfassung, Analyse und technische Berichterstattung. INBS unterstützt derzeit mehr als 450 Kunden in 24 Ländern mit 18 Vertriebspartnern. Das Unternehmen plant, 2025 in den US-Markt einzutreten und strebt die FDA-Zulassung für sein Opiat-Testsystem für Codein an.
- Successful validation of system security through rigorous cybersecurity and electromagnetic compatibility testing
- Confirmation of ultra-precise detection capability using advanced Ultra-Micro Balance scale technology
- Strong global presence with 450+ accounts across 24 countries and 18 distribution partners
- Planned expansion into multi-billion dollar U.S. market in 2025
- FDA 510(k) clearance still pending and requiring additional data submission
- Significant resource investment with 6,000+ hours in testing and development
Insights
INBS advances FDA 510(k) submission with new sweat detection data, strengthening chances for US market entry in 2025.
Intelligent Bio Solutions (INBS) has achieved a significant regulatory milestone in their FDA 510(k) submission for their Intelligent Fingerprinting Drug Screening System. The company has successfully completed extensive testing that demonstrates their technology's ability to detect trace sweat volumes at the ultra-micro level (measuring down to 0.0000001 grams) and shows system resilience across diverse operating conditions.
The regulatory progress includes comprehensive cybersecurity validation through penetration testing and electromagnetic compatibility testing – critical elements that the FDA increasingly scrutinizes for modern diagnostic devices. This proactive approach to security compliance reduces regulatory risk and potential delays in the approval process.
From a regulatory perspective, INBS appears to be navigating the FDA process methodically, with several positive indicators: (1) they report constructive dialogue with the FDA, (2) they've engaged specialized FDA consultants, and (3) they're planning to submit additional findings in August. The company claims to have invested over
The timing is particularly noteworthy – INBS aims to enter the US market in 2025, which aligns with their current regulatory timeline if their August submission progresses without significant issues. They already support 450 accounts across 24 countries with 18 distribution partners, demonstrating existing market validation for their technology while pursuing FDA clearance specifically for their opiate test system for codeine.
This regulatory progress represents a critical de-risking step toward accessing the substantial US market opportunity for non-invasive drug testing in safety-critical industries, where traditional testing methods face increasing challenges related to privacy, convenience, and timeliness.
Data confirms Company’s ability to detect trace sweat volumes at ultra-micro level
System demonstrates resilience across diverse conditions
NEW YORK, July 23, 2025 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the successful collection of new data that further reinforces the security and performance of its Intelligent Fingerprinting Drug Screening System, strengthening its FDA 510(k) submission.
"Our ongoing dialogue with the FDA throughout the 510(k) process has been constructive and forward-looking," said Peter Passaris, Vice President of Product Development. "With the support of specialized FDA consultants and expert third-party partners, our team has worked diligently to address each question thoroughly. We are planning to submit our findings to the FDA in August, along with the new data collected."
As part of this process, the Company completed rigorous cybersecurity testing, including penetration testing and electromagnetic compatibility testing, to validate the resilience of its system. These proactive measures confirmed the product's strength in secure and varied operating environments, allowing for targeted enhancements that elevate the overall security and reliability of the platform.
The Company also reaffirmed the reliability and accuracy of its technology through advanced quantification techniques, including human eccrine sweat testing. To measure the minute volumes of sweat present in a single fingerprint, volumes invisible to the human eye, the Company used an Ultra-Micro Balance scale, one of the most sensitive instruments available. Capable of measuring down to 0.0000001 grams, approximately 10 million times lighter than a U.S. one-dollar bill, this tool, because of its precision and sensitivity, has confirmed the Company’s existing ability to detect and analyze trace levels of sweat in a single fingerprint.
“As we near the final resubmission deadline for our 510(k) process, our focus has been twofold: addressing the FDA’s questions and enhancing the overall quality of our submission,” said Harry Simeonidis, President and CEO at Intelligent Bio Solutions. “With strategic input from regulatory consultants and FDA submission specialists, our R&D team has invested over 6,000 hours into testing, data aggregation, analysis, and technical reporting. We’re currently in a far stronger position than at any prior stage in this process.”
INBS’s innovative drug testing technology uses fingerprint sweat analysis to detect common drugs of abuse, addressing growing demand from safety-critical industries focused on ensuring workplace safety. The Company currently supports more than 450 accounts across 24 countries, with 18 distribution partners expanding its global reach. As INBS continues to pursue FDA clearance for its opiate test system for codeine, it continues to develop its plans to enter the multi-billion dollar U.S. market in 2025 and scale its international operations.
About Intelligent Bio Solutions Inc.
Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering intelligent, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The Company’s current customer segments outside the US include construction, manufacturing and engineering, transport and logistics firms, mining, drug treatment organizations, and coroners.
For more information, visit https://ibs.inc/
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, Intelligent Bio Solutions Inc.’s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefit from its partnerships and collaborations, and secure regulatory approvals, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology, including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, included in Intelligent Bio Solutions’ public filings filed with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
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