Intelligent Bio Solutions Provides Update on FDA 510(k) Clearance Process for Intelligent Fingerprinting Drug Screening System
Intelligent Bio Solutions (Nasdaq: INBS) provided an update on the FDA 510(k) clearance process for its Intelligent Fingerprinting Drug Screening System. Following their December 2024 submission, the FDA issued an Additional Information request in February 2025 with over 70 items to address.
After responding in August 2025, the FDA has requested new additional information requiring a new 510(k) notification submission. Being a first-of-its-kind sweat-based device, the extensive requirements are not uncommon for breakthrough technologies. The company expects to provide an investor update on the revised FDA clearance timeline within 10 days.
Meanwhile, INBS continues to expand its international business operations outside the U.S. market.
Intelligent Bio Solutions (Nasdaq: INBS) ha fornito un aggiornamento sul processo di autorizzazione FDA 510(k) per il suo Intelligent Fingerprinting Drug Screening System. Dopo la presentazione di dicembre 2024, la FDA ha emesso una richiesta di informazioni aggiuntive a febbraio 2025 con oltre 70 elementi da affrontare. Dopo aver risposto nell'agosto 2025, la FDA ha richiesto nuove informazioni supplementari che richiedono una presentazione di notifica 510(k). Essendo un dispositivo basato sul sudore di prima categoria, i requisiti estesi non sono insoliti per tecnologie di avanguardia. L'azienda prevede di fornire un aggiornamento agli investitori sulla timeline rivista di autorizzazione FDA entro 10 giorni.
Nel frattempo, INBS continua ad espandere le sue operazioni commerciali internazionali al di fuori del mercato degli Stati Uniti.
Intelligent Bio Solutions (Nasdaq: INBS) proporcionó una actualización sobre el proceso de autorización 510(k) de la FDA para su Intelligent Fingerprinting Drug Screening System. Tras su presentación de diciembre de 2024, la FDA emitió una solicitud de información adicional en febrero de 2025 con más de 70 ítems a abordar. Después de responder en agosto de 2025, la FDA ha solicitado nueva información adicional que requiere una nueva notificación 510(k). Al ser un dispositivo pionero basado en sudor, los requisitos extensos no son inusuales para tecnologías innovadoras. La empresa espera proporcionar una actualización a los inversionistas sobre el cronograma revisado de la autorización de la FDA dentro de 10 días.
Mientras tanto, INBS continúa expandiendo sus operaciones comerciales internacionales fuera del mercado de EE. UU.
Intelligent Bio Solutions (Nasdaq: INBS)는 자사의 Intelligent Fingerprinting Drug Screening System에 대한 FDA 510(k) 승인 절차에 대해 업데이트를 제공했습니다. 2024년 12월 제출 후 2025년 2월 FDA는 70개 이상의 항목을 다루어야 한다는 추가 정보 요청을 발행하였습니다. 2025년 8월에 응답한 후, FDA는 새로운 510(k) 알림 제출을 필요로 하는 새로운 추가 정보를 요청했습니다. 땀 기반의 첫 번째 장치이므로 광범위한 요건은 혁신 기술에 흔한 일입니다. 회사는 수정된 FDA 승인 일정에 대한 투자자 업데이트를 10일 이내에 제공할 것으로 기대합니다.
한편 INBS는 미국 외 국제 사업 운영도 확장하고 있습니다.
Intelligent Bio Solutions (Nasdaq: INBS) a fourni une mise à jour sur le processus d'autorisation FDA 510(k) pour son Intelligent Fingerprinting Drug Screening System. Suite à la soumission de décembre 2024, la FDA a émis une demande d'informations supplémentaires en février 2025 couvrant plus de 70 éléments à traiter. Après avoir répondu en août 2025, la FDA a demandé de nouvelles informations supplémentaires nécessitant une nouvelle notification 510(k). Étant un dispositif innovant basé sur la sueur, les exigences étendues ne sont pas inhabituelles pour les technologies de pointe. L'entreprise prévoit de fournir une mise à jour aux investisseurs sur le calendrier révisé de l'autorisation FDA dans 10 jours.
Entre-temps, INBS poursuit l'expansion de ses activités commerciales internationales en dehors du marché américain.
Intelligent Bio Solutions (Nasdaq: INBS) hat ein Update zum FDA 510(k)-Freigabeprozess für sein Intelligent Fingerprinting Drug Screening System gegeben. Nach der Einreichung im Dezember 2024 hat die FDA im Februar 2025 eine Anfrage zu ergänzenden Informationen mit über 70 Punkten gestellt, die bearbeitet werden müssen. Nachdem im August 2025 darauf geantwortet wurde, hat die FDA neue zusätzliche Informationen angefordert, die eine neue 510(k)-Benachrichtigung erfordern. Da es sich um ein erstes, schweißbasiertes Gerät handelt, sind die umfangreichen Anforderungen für Durchbruchtechnologien nicht ungewöhnlich. Das Unternehmen erwartet, innerhalb von 10 Tagen ein Investoren-Update zum überarbeiteten FDA-Freigabezeitplan bereitzustellen.
Unterdessen erweitert INBS seine internationalen Geschäftstätigkeiten außerhalb des US-Marktes.
Intelligent Bio Solutions (Nasdaq: INBS) قدمت تحديثاً لعملية موافقة FDA 510(k) على نظام فحص المخدرات بالبصمة الذكية. بعد تقديمها في ديسمبر 2024، أصدرت FDA في فبراير 2025 طلب معلومات إضافية يشمل أكثر من 70 عنصرًا يجب معالجتها. بعد الرد في أغسطس 2025، طلبت FDA معلومات إضافية جديدة تتطلب إخطار 510(k) جديد. وبما أنه جهاز يعتمد على العرق كأول جهاز من نوعه، فإن المتطلبات الواسعة ليست شائعة بالنسبة للتقنيات الرائدة. تتوقع الشركة أن تزود المستثمرين بتحديث حول الجدول الزمني المعدل لموافقة FDA خلال 10 أيام.
في هذه الأثناء، تواصل INBS توسيع عملياتها التجارية الدولية خارج السوق الأمريكية.
Intelligent Bio Solutions (纳斯达克: INBS) 就其 Intelligent Fingerprinting Drug Screening System 的 FDA 510(k) 审批流程提供了更新。2024 年 12 月提交后，FDA 于 2025 年 2 月发出信息补充请求，涉及超过 70 项需处理。在 2025 年 8 月作出回应后，FDA 要求提供新的额外信息，需提交一个 新的 510(k) 通知。作为首创的以汗液为基础的设备，广泛的要求对突破性技术并不罕见。公司预计将在 10 天内向投资者提供修订后的 FDA 审批时间表更新。
与此同时，INBS 继续在美国市场之外扩大其国际业务运营。
- Company's international business continues to grow and expand globally
- FDA provided constructive feedback for the novel technology
- Additional data collected throughout the process strengthens the product's validation
- FDA requires a new 510(k) notification submission, extending the clearance timeline
- Over 70 additional information items needed to be addressed
- No comparable cleared sweat-based product exists, requiring extensive validation
Insights
FDA requires INBS to resubmit 510(k) for novel fingerprint drug screening system, extending timeline for potential US market entry.
Intelligent Bio Solutions' update on their FDA 510(k) process reveals significant regulatory hurdles for their fingerprint-based drug screening technology. The company initially submitted their application in December 2024, received over 70 questions from the FDA in February 2025, and submitted responses in August 2025. Despite addressing most concerns, the FDA now requires a complete resubmission of the 510(k) notification with additional information.
This setback is not entirely unexpected for a first-of-its-kind device with no comparable sweat-based products on the market. Novel technologies typically face more intensive scrutiny from regulators to ensure safety and efficacy. The company will provide an updated timeline within 10 days, but this development will certainly delay market entry beyond their original expectations.
The lack of a definitive new timeline is concerning, as 510(k) reviews typically take 3-6 months once accepted. A complete resubmission essentially resets this clock. While the company states they've collected additional supporting data throughout this process, their characterization of the FDA's requirements as "not uncommon for breakthrough technologies" suggests they're facing substantial regulatory challenges that could extend well into 2026.
Importantly, INBS continues to operate in international markets and the US "Forensic Use Only" market (which doesn't require FDA clearance), providing some revenue stream during this extended regulatory process. However, the broader US healthcare market remains inaccessible until clearance is obtained.
NEW YORK, Sept. 17, 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 provided an update on its FDA 510(k) clearance process for its Intelligent Fingerprinting Drug Screening System.
In December 2024, INBS submitted its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for review and clearance of its Intelligent Fingerprinting Drug Screening System. As expected, the FDA reviewed and responded with questions by issuing an Additional Information (AI) request in February 2025. This AI request consisted of over 70 items to be addressed by the Company. With the support of specialized FDA consultants and expert third-party partners, INBS responded to the FDA’s questions and submitted additional information in August 2025.
The FDA appeared to be satisfied with the majority of responses to the items and has responded with a request for new additional information that requires the Company to resubmit a new 510(k) notification. As a first-of-its-kind device with no comparable cleared or approved sweat-based product currently on the market, the Company’s Intelligent Fingerprinting Drug Screening System requires extensive supporting information to validate its performance. The practical feedback received from the FDA is not uncommon for breakthrough technologies.
INBS is in the process of evaluating the FDA’s questions and is currently in consultation with its specialized FDA consultants. The Company expects to have an investor update in the next ten days outlining an updated timeline for FDA clearance.
“The FDA’s feedback provides constructive clarity on the additional information it requires to advance our application,” said Harry Simeonidis, President and CEO at Intelligent Bio Solutions. “We are confident in the capabilities of our technology, and we remain fully committed to bringing our innovative solution to the U.S. market. We will work to respond to the FDA’s additional questions to support validation of our device, in order to resubmit our 510(k) Notification as soon as possible. The progress we have made so far in terms of additional data collected to substantiate the strength of our product throughout this process places us in a strong position as we work toward clearance. Importantly, our international business continues to grow, enabling us to maintain commercial progress globally while pursuing U.S. clearance outside of the Forensic Use Only market.”
The Company continues to advance its commercial activities outside the U.S., developing new partnerships and driving sales growth while pursuing further international market penetration.
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 U.S. 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.
Company Contact
Intelligent Bio Solutions Inc.
info@ibs.inc
LinkedIn | Twitter
Investor & Media Contact
Valter Pinto, Managing Director
KCSA Strategic Communications
PH: (212) 896-1254
INBS@kcsa.com
FAQ
What is the current status of INBS's FDA 510(k) clearance for the Intelligent Fingerprinting Drug Screening System?
When will Intelligent Bio Solutions (INBS) provide the next update on FDA clearance timeline?
Why does the INBS Fingerprinting Drug Screening System require extensive FDA documentation?
Can INBS sell its Fingerprinting Drug Screening System while waiting for FDA clearance?
What happened after INBS's initial FDA 510(k) submission in December 2024?
