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Intelligent Bio Solutions clears cybersecurity items for FDA 510(k) filing

Thu, 23 Jul 2026 08:30:43 -0400

Intelligent Bio Solutions Inc. (Nasdaq: INBS) announced it has resolved all cybersecurity and software-related review items required for its planned FDA 510(k) submission, according to a press release dated July 23, 2026.

The company said it completed a full remediation cycle following independent third-party penetration testing. All medium-risk cybersecurity vulnerabilities were remediated, and low-risk vulnerabilities were reduced from 11 to 2. The company said the remaining items are supported by a risk-based justification confirming no impact on device safety, effectiveness, or performance. All 19 software bill of materials (SBOM) vulnerabilities were also fully resolved, with independent third-party verification confirming no remaining

Intelligent Bio Solutions Achieves Key Milestone Ahead of Planned FDA 510(k) Submission, Advancing Toward Planned U.S. Market Entry

Thu, 23 Jul 2026 08:30:00 -0400

Company has addressed final review items from penetration testing and finalized cybersecurity and software documentation

510(k) package submission on track for calendar H2 2026, targeting planned entry into multi-billion-dollar U.S. drug screening market

NEW YORK, July 23, 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 has addressed all the cybersecurity and software-related review items for its upcoming FDA 510(k) submission. This follows the Company’s recent completion of independent third-party penetration testing and confirms

Intelligent Bio Solutions Achieves Key Milestone Ahead of Planned FDA 510(k) Submission, Advancing Toward Planned U.S. Market Entry

Thu, 23 Jul 2026 08:30:00 -0400

Company has addressed final review items from penetration testing and finalized cybersecurity and software documentation

510(k) package submission on track for calendar H2 2026, targeting planned entry into multi-billion-dollar U.S. drug screening market

Intelligent Bio Solutions Achieves Key Milestone Ahead of Planned FDA 510(k) Submission, Advancing Toward Planned U.S. Market Entry

Thu, 23 Jul 2026 08:30:00 -0400

Company has addressed final review items from penetration testing and finalized cybersecurity and software documentation

510(k) package submission on track for calendar H2 2026, targeting planned entry into multi-billion-dollar U.S. drug screening market

Intelligent Bio Solutions Achieves Key Milestone Ahead of Planned FDA 510(k) Submission, Advancing Toward Planned U.S. Market Entry

Thu, 23 Jul 2026 08:30:00 -0400

Company has addressed final review items from penetration testing and finalized cybersecurity and software documentation

510(k) package submission on track for calendar H2 2026, targeting planned entry into multi-billion-dollar U.S. drug screening market

Intelligent Bio Solutions completes precision testing for FDA submission

Tue, 21 Jul 2026 08:30:11 -0400

Intelligent Bio Solutions Inc. (NASDAQ: INBS) announced the completion of precision testing for its Intelligent Fingerprinting Drug Screening System, a step toward an FDA 510(k) submission for U.S. market clearance of the device for detecting the opiate codeine.

According to the company, the testing included more than 1,600 tests conducted across three production runs and three independent sites. Results showed consistent performance across all runs and locations, which the company said confirms the system's suitability for workplace and other drug screening environments.

"Completing over 1,600 tests across multiple independent sites and production runs puts us firmly on track for our FDA 510(k)

Intelligent Bio Solutions Completes Precision Testing, Strengthening FDA 510(k) Submission Package Ahead of Planned Entry into Multi-Billion-Dollar U.S. Drug Screening Market

Tue, 21 Jul 2026 08:30:00 -0400

Precision testing confirms reproducibility across more than 1,600 tests, three production runs, and three independent testing sites

NEW YORK, July 21, 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 precision testing, a key component of the Company's FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine.

The precision testing, conducted following the Company's clinical cut-off adjustment, confirmed that the Intelligent Fingerprinting Drug Screening System

Intelligent Bio Solutions Completes Precision Testing, Strengthening FDA 510(k) Submission Package Ahead of Planned Entry into Multi-Billion-Dollar U.S. Drug Screening Market

Tue, 21 Jul 2026 08:30:00 -0400

Precision testing confirms reproducibility across more than 1,600 tests, three production runs, and three independent testing sites

The precision testing, conducted following the Company's clinical cut-off adjustment, confirmed that the Intelligent Fingerprinting Drug Screening System

Intelligent Bio Solutions Completes Precision Testing, Strengthening FDA 510(k) Submission Package Ahead of Planned Entry into Multi-Billion-Dollar U.S. Drug Screening Market

Tue, 21 Jul 2026 08:30:00 -0400

Precision testing confirms reproducibility across more than 1,600 tests, three production runs, and three independent testing sites

The precision testing, conducted following the Company's clinical cut-off adjustment, confirmed that the Intelligent Fingerprinting Drug Screening System

Intelligent Bio Solutions Completes Precision Testing, Strengthening FDA 510(k) Submission Package Ahead of Planned Entry into Multi-Billion-Dollar U.S. Drug Screening Market

Tue, 21 Jul 2026 08:30:00 -0400

Precision testing confirms reproducibility across more than 1,600 tests, three production runs, and three independent testing sites

The precision testing, conducted following the Company's clinical cut-off adjustment, confirmed that the Intelligent Fingerprinting Drug Screening System

Intelligent Bio Solutions starts interference study for FDA drug screening submission

Tue, 16 Jun 2026 08:30:37 -0400

Intelligent Bio Solutions Inc. (NASDAQ: INBS) has initiated an Interference Study to support its FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for codeine detection, according to a press release from the company.

The study will enroll 75 healthy adult participants who will be evaluated under both undosed and dosed conditions while handling substances that could potentially interfere with test results. The protocol includes multiple collection time points, with results confirmed via liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis.

The company has partnered again with CenExel Clinical Research, Inc. to conduct the study, which will follow FDA

Intelligent Bio Solutions starts interference study for FDA drug screening submission

Tue, 16 Jun 2026 08:30:37 -0400

The company has partnered again with CenExel Clinical Research, Inc. to conduct the study, which will follow FDA

Intelligent Bio Solutions Initiates Clinical Study Supporting FDA Clearance and Planned U.S. Market Entry

Tue, 16 Jun 2026 08:30:00 -0400

Interference Study designed to validate system specificity in the presence of potentially interfering substances commonly encountered in real-world settings

Company expects to complete the study by mid-July 2026, with plans to include results in its FDA 510(k) submission package, along with data from the concurrent Method Comparison Study

NEW YORK, June 16, 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 initiation of an Interference Study to support its FDA 510(k) submission for

Intelligent Bio Solutions Initiates Clinical Study Supporting FDA Clearance and Planned U.S. Market Entry

Tue, 16 Jun 2026 08:30:00 -0400

Interference Study designed to validate system specificity in the presence of potentially interfering substances commonly encountered in real-world settings

Company expects to complete the study by mid-July 2026, with plans to include results in its FDA 510(k) submission package, along with data from the concurrent Method Comparison Study

Intelligent Bio Solutions Initiates Clinical Study Supporting FDA Clearance and Planned U.S. Market Entry

Tue, 16 Jun 2026 08:30:00 -0400

Interference Study designed to validate system specificity in the presence of potentially interfering substances commonly encountered in real-world settings

Company expects to complete the study by mid-July 2026, with plans to include results in its FDA 510(k) submission package, along with data from the concurrent Method Comparison Study

Intelligent Bio Solutions Initiates Clinical Study Supporting FDA Clearance and Planned U.S. Market Entry

Tue, 16 Jun 2026 08:30:00 -0400

Interference Study designed to validate system specificity in the presence of potentially interfering substances commonly encountered in real-world settings

Company expects to complete the study by mid-July 2026, with plans to include results in its FDA 510(k) submission package, along with data from the concurrent Method Comparison Study

Intelligent Bio Solutions to Participate in Planet MicroCap Las Vegas Conference over June 16-18

Thu, 04 Jun 2026 08:30:00 -0400

NEW YORK, June 04, 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 management team will participate in the Planet MicroCap Conference on June 16-18, 2026, in Las Vegas, NV.

Conference Details
Date: June 16-18, 2026
Location: Bellagio Hotel & Casino, Las Vegas
Presentation Date and Time: Wednesday, June 17, 2026, at 8:00 – 8:30 AM PDT
Presentation Location: Track 7 – Donatello 3
Registration: Interested investors can register to attend here

Intelligent Bio Solutions to Participate in Planet MicroCap Las Vegas Conference over June 16-18

Thu, 04 Jun 2026 08:30:00 -0400

Intelligent Bio Solutions to Participate in Planet MicroCap Las Vegas Conference over June 16-18

Thu, 04 Jun 2026 08:30:00 -0400

Intelligent Bio Solutions to Participate in Planet MicroCap Las Vegas Conference over June 16-18

Thu, 04 Jun 2026 08:30:00 -0400

Intelligent Bio Solutions begins FDA study for drug screening device

Tue, 02 Jun 2026 08:30:53 -0400

Intelligent Bio Solutions Inc. (NASDAQ: INBS) announced the start of a multi-site method comparison study to support its FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for opiate codeine detection.

The company partnered with CenExel Clinical Research, Inc. to conduct the study, which will evaluate the accuracy of the fingerprint-based drug screening system when operated by intended end-users across multiple clinical sites. The study will enroll 135 donor participants randomized into dosing groups with demographics reflecting U.S. population diversity.

Nine operator participants representing typical workplace drug screening personnel will collect and analyze fingerprint sweat specimens. The

Intelligent Bio Solutions Commences Multi-Site Method Comparison Study for FDA 510(k) Submission

Tue, 02 Jun 2026 08:30:00 -0400

Study designed to validate accuracy and real-world workplace performance of the Intelligent Fingerprinting Drug Screening System

Company expects to complete enrollment and data collection by the end of July, 2026

NEW YORK, June 02, 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 initiation of a multi-site Method Comparison Study to support its FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for the opiate codeine.

The Company

Intelligent Bio Solutions Commences Multi-Site Method Comparison Study for FDA 510(k) Submission

Tue, 02 Jun 2026 08:30:00 -0400

The Company

Intelligent Bio Solutions Commences Multi-Site Method Comparison Study for FDA 510(k) Submission

Tue, 02 Jun 2026 08:30:00 -0400

The Company

Intelligent Bio Solutions Commences Multi-Site Method Comparison Study for FDA 510(k) Submission

Tue, 02 Jun 2026 08:30:00 -0400

The Company