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Intelligent Bio Solutions to Host Virtual Fireside Chat on September 24th at 4:30 p.m. ET

Thu, 10 Sep 2026 08:30:00 -0400

Management to discuss FDA 510(k) submission, clinical data, and commercial progress outside the U.S.

NEW YORK, Sept. 10, 2026 (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 that it will host a virtual fireside chat on Thursday, September 24, 2026, at 4:30 p.m. ET.

The moderated discussion will feature Harry Simeonidis, President and CEO, and Peter Passaris, Vice President of Product Development. Topics will include the Company’s FDA 510(k) submission for its Intelligent Fingerprinting Drug Screening System, the supporting

Intelligent Bio Solutions to Host Virtual Fireside Chat on September 24th at 4:30 p.m. ET

Thu, 10 Sep 2026 08:30:00 -0400

Management to discuss FDA 510(k) submission, clinical data, and commercial progress outside the U.S.

Intelligent Bio Solutions files FDA 510(k) for fingerprint drug screening

Wed, 09 Sep 2026 08:30:20 -0400

Intelligent Bio Solutions Inc. (Nasdaq: INBS) has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration, seeking regulatory clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine, according to a press release dated Sept. 9, 2026.

The submission package was developed in partnership with Cliantha Research and CenExel Clinical Research Inc. and includes clinical studies conducted in accordance with FDA guidance and International Council for Harmonisation Good Clinical Practice standards. The package contains 18 detailed test reports supported by more than 170 attachments, generated from over 18,000 hours of data collection and more

Intelligent Bio Solutions Submits FDA 510(k) Package for Intelligent Fingerprinting Drug Screening System, Seeking U.S. Market Clearance

Wed, 09 Sep 2026 08:30:00 -0400

Submission package includes Method Comparison Study, which delivered accuracy above 98%, sensitivity above 94%, and 100% specificity across three independent U.S. clinical sites

NEW YORK, Sept. 09, 2026 (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 submission of its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA), seeking regulatory clearance of its Intelligent Fingerprinting Drug Screening System (the “System”) for detection of the opiate codeine. The submission represents the culmination of data from a structured, multi-study clinical

Intelligent Bio Solutions Submits FDA 510(k) Package for Intelligent Fingerprinting Drug Screening System, Seeking U.S. Market Clearance

Wed, 09 Sep 2026 08:30:00 -0400

Submission package includes Method Comparison Study, which delivered accuracy above 98%, sensitivity above 94%, and 100% specificity across three independent U.S. clinical sites

Intelligent Bio Solutions reports 98% accuracy in drug screening study

Tue, 01 Sep 2026 08:31:20 -0400

Intelligent Bio Solutions Inc. (NASDAQ: INBS) reported results from a method comparison study of its Intelligent Fingerprinting Drug Screening System, showing overall accuracy of 98.2% for detecting the opiate codeine across three independent U.S. clinical sites.

The study recorded sensitivity of 94.6%, specificity of 100%, and zero false positives across a combined 218 samples. Results were measured against a liquid chromatography-tandem mass spectrometry reference method. The figures represent an improvement from a prior study conducted in November 2024, which reported approximately 94% accuracy and 82% sensitivity.

Individual site accuracy ranged from 97.3% to 98.7%. False negatives totaled four across all three sites,

Intelligent Bio Solutions Achieves Above 98% Accuracy in Method Comparison Study, Supporting Planned 2026 FDA 510(k) Submission

Tue, 01 Sep 2026 08:31:00 -0400

Multi-site clinical study delivers strong performance data for Intelligent Fingerprinting Drug Screening System

NEW YORK, Sept. 01, 2026 (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 results of its latest Method Comparison Study for its Intelligent Fingerprinting Drug Screening System (the “System”) to detect the opiate codeine. Conducted across three independent U.S. clinical sites, the study represents the most comprehensive evaluation of the System in the Company's FDA 510(k) clinical study program. The study results show substantially improved performance compared

Intelligent Bio Solutions Achieves Above 98% Accuracy in Method Comparison Study, Supporting Planned 2026 FDA 510(k) Submission

Tue, 01 Sep 2026 08:31:00 -0400

Multi-site clinical study delivers strong performance data for Intelligent Fingerprinting Drug Screening System

Intelligent Bio Solutions raises $5M in private placement

Tue, 01 Sep 2026 08:30:14 -0400

Intelligent Bio Solutions Inc. (Nasdaq: INBS) has entered into a securities purchase agreement with a single existing institutional investor for a private placement priced at-the-market under Nasdaq rules, the company announced in a press release.

The transaction involves the issuance of 2,036,659 shares of common stock, or Series M pre-funded warrants in lieu thereof, along with Series N-1 and Series N-2 warrants each covering up to 2,036,659 shares of common stock. The combined purchase price is $2.455 per share and associated warrants, with expected gross proceeds of approximately $5.0 million before placement agent fees and other expenses.

Both the Series N-1 and

Intelligent Bio Solutions Announces Private Placement of up to $15 Million to a Single Existing Institutional Investor Priced At-the-Market Under Nasdaq Rules

Tue, 01 Sep 2026 08:30:00 -0400

$5 Million Upfront at Closing and $5 Million Tranche Warrant Callable by the Company Following FDA 510(k) Clearance of Intelligent Fingerprinting Drug Screening System

NEW YORK, Sept. 01, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (“INBS” or the “Company”) (Nasdaq: INBS), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced that it has entered into a securities purchase agreement with a single existing institutional investor to issue, in a private placement priced at-the-market under Nasdaq rules, 2,036,659 shares of common stock (or Series M pre-funded warrants in lieu thereof), Series N-1 warrants to purchase

Intelligent Bio Solutions Announces Private Placement of up to $15 Million to a Single Existing Institutional Investor Priced At-the-Market Under Nasdaq Rules

Tue, 01 Sep 2026 08:30:00 -0400

$5 Million Upfront at Closing and $5 Million Tranche Warrant Callable by the Company Following FDA 510(k) Clearance of Intelligent Fingerprinting Drug Screening System

Intelligent Bio Solutions Reports Fiscal 2026 Full-Year Revenue Growth of 38% Year-over-Year, Driven by Reader Installed Base and High-Margin Cartridge Growth

Wed, 19 Aug 2026 08:30:00 -0400

Reader installed base grew 22% year-over-year, driving a 35% increase in total consumable cartridges to over 100,000 units

Full year gross profit margin expanded to 48.63%, up 778 basis points year-over-year

502 active customers as of June 30, 2026, reflecting continued commercial momentum across safety-critical industries

Company made substantial progress toward FDA clearance and planned market expansion during the year

NEW YORK, Aug. 19, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today

Intelligent Bio Solutions Reports Fiscal 2026 Full-Year Revenue Growth of 38% Year-over-Year, Driven by Reader Installed Base and High-Margin Cartridge Growth

Wed, 19 Aug 2026 08:30:00 -0400

Reader installed base grew 22% year-over-year, driving a 35% increase in total consumable cartridges to over 100,000 units

Full year gross profit margin expanded to 48.63%, up 778 basis points year-over-year

502 active customers as of June 30, 2026, reflecting continued commercial momentum across safety-critical industries

Company made substantial progress toward FDA clearance and planned market expansion during the year

Intelligent Bio Solutions Reports Fiscal 2026 Full-Year Revenue Growth of 38% Year-over-Year, Driven by Reader Installed Base and High-Margin Cartridge Growth

Wed, 19 Aug 2026 08:30:00 -0400

Reader installed base grew 22% year-over-year, driving a 35% increase in total consumable cartridges to over 100,000 units

Full year gross profit margin expanded to 48.63%, up 778 basis points year-over-year

502 active customers as of June 30, 2026, reflecting continued commercial momentum across safety-critical industries

Company made substantial progress toward FDA clearance and planned market expansion during the year

Intelligent Bio Solutions Reports Fiscal 2026 Full-Year Revenue Growth of 38% Year-over-Year, Driven by Reader Installed Base and High-Margin Cartridge Growth

Wed, 19 Aug 2026 08:30:00 -0400

Reader installed base grew 22% year-over-year, driving a 35% increase in total consumable cartridges to over 100,000 units

Full year gross profit margin expanded to 48.63%, up 778 basis points year-over-year

502 active customers as of June 30, 2026, reflecting continued commercial momentum across safety-critical industries

Company made substantial progress toward FDA clearance and planned market expansion during the year

Intelligent Bio Solutions wins ISO 13485 recertification for drug screening

Mon, 17 Aug 2026 08:31:25 -0400

Intelligent Bio Solutions Inc. (NASDAQ: INBS) announced that its Intelligent Fingerprinting Drug Screening business has been recertified to the ISO 13485:2016 quality management system standard by the British Standards Institution (BSI).

The recertification takes effect October 14, 2026, and is valid for three years. The company also completed recertification to ISO 9001:2015.

The U.S. FDA's amended Quality Management System Regulation (QMSR), which came into effect February 2, 2026, incorporated ISO 13485:2016 by reference. The company said its existing certification, held as an FDA-registered facility in the UK, aligns with that standard.

Callistus Sequeira, Vice President of Global Quality & Operations at Intelligent Bio

Intelligent Bio Solutions Strengthens Quality Management Credentials with ISO Recertification

Mon, 17 Aug 2026 08:30:00 -0400

Recertification aligns with the FDA's newly amended Quality Management System Regulation and supports the Company's regulatory strategy as it pursues FDA clearance

NEW YORK, Aug. 17, 2026 (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 that its Intelligent Fingerprinting Drug Screening business has been recertified to the ISO 13485:2016 quality management system standard, the internationally recognized benchmark for medical device manufacturers. The recertification, issued by the British Standards Institution (BSI), is effective October 14, 2026, and will be valid for three

Intelligent Bio Solutions Strengthens Quality Management Credentials with ISO Recertification

Mon, 17 Aug 2026 08:30:00 -0400

Recertification aligns with the FDA's newly amended Quality Management System Regulation and supports the Company's regulatory strategy as it pursues FDA clearance

Intelligent Bio Solutions Strengthens Quality Management Credentials with ISO Recertification

Mon, 17 Aug 2026 08:30:00 -0400

Recertification aligns with the FDA's newly amended Quality Management System Regulation and supports the Company's regulatory strategy as it pursues FDA clearance

Intelligent Bio Solutions Strengthens Quality Management Credentials with ISO Recertification

Mon, 17 Aug 2026 08:30:00 -0400

Recertification aligns with the FDA's newly amended Quality Management System Regulation and supports the Company's regulatory strategy as it pursues FDA clearance

Intelligent Bio Solutions completes drug screening clinical study

Tue, 11 Aug 2026 08:32:25 -0400

Intelligent Bio Solutions Inc. (NASDAQ: INBS) announced the completion of a multi-site Method Comparison Study for its Intelligent Fingerprinting Drug Screening System, concluding all clinical data collection under the company's FDA 510(k) clinical study program.

The study was conducted across three independent U.S. clinical sites over three weeks, following ICH GCP guidelines, in partnership with CenExel Clinical Research, Inc. A total of 135 participants were enrolled, with the study population structured to reflect U.S. demographic diversity. Nine operator participants representing typical workplace drug screening personnel administered the screening process.

The study was designed to evaluate whether users in occupational health, human resources,

Intelligent Bio Solutions Announces Completion of Method Comparison Study for the Intelligent Fingerprinting Drug Screening System

Tue, 11 Aug 2026 08:30:00 -0400

All clinical data collection across the Company's FDA 510(k) clinical study program is complete; FDA submission on track for second half of 2026

NEW YORK, Aug. 11, 2026 (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 completion of its multi-site Method Comparison Study for the Intelligent Fingerprinting Drug Screening System, one of several studies underpinning the Company's FDA 510(k) submission for U.S. market clearance for detection of the opiate codeine. All clinical data collection across the Company's FDA 510(k) clinical

Intelligent Bio Solutions Announces Completion of Method Comparison Study for the Intelligent Fingerprinting Drug Screening System

Tue, 11 Aug 2026 08:30:00 -0400

All clinical data collection across the Company's FDA 510(k) clinical study program is complete; FDA submission on track for second half of 2026

Intelligent Bio Solutions Announces Completion of Method Comparison Study for the Intelligent Fingerprinting Drug Screening System

Tue, 11 Aug 2026 08:30:00 -0400

All clinical data collection across the Company's FDA 510(k) clinical study program is complete; FDA submission on track for second half of 2026

Intelligent Bio Solutions Announces Completion of Method Comparison Study for the Intelligent Fingerprinting Drug Screening System

Tue, 11 Aug 2026 08:30:00 -0400

All clinical data collection across the Company's FDA 510(k) clinical study program is complete; FDA submission on track for second half of 2026