Press Releases April 16, 2026 08:00 PM

Intelligent Bio Solutions Advances Upcoming FDA 510(k) Submission, Successfully Completes Penetration Testing with No Major Vulnerabilities Identified

Intelligent Bio Solutions completes successful penetration testing ahead of FDA 510(k) submission, enhancing security and regulatory prospects.

By Derek Hwang INBS
Intelligent Bio Solutions Advances Upcoming FDA 510(k) Submission, Successfully Completes Penetration Testing with No Major Vulnerabilities Identified
INBS

Intelligent Bio Solutions Inc. announced the successful completion of penetration testing with no major vulnerabilities identified as part of its FDA 510(k) submission process. The company also implemented enhanced security upgrades to its drug testing technology, aimed at safeguarding data and ensuring regulatory compliance. Clearance from the FDA would open new revenue opportunities in the U.S. drug screening market.

Key Points

  • Completion of penetration testing confirmed the security robustness of Intelligent Bio Solutions' drug testing system.
  • Enhanced security features include encrypted identification tags and firmware safeguards to prevent unauthorized access and cyber threats.
  • FDA 510(k) clearance would allow entry and expansion into the U.S. multi-billion-dollar drug screening market, impacting sectors like healthcare, workplace safety, transportation, and manufacturing.

NEW YORK, April 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 the successful completion of penetration testing as part of its upcoming FDA 510(k) submission. The testing identified no major vulnerabilities, verified the robustness of the Company's existing security infrastructure, and strengthened its regulatory submission to the FDA.

In conjunction with the penetration testing, INBS implemented additional security upgrades to its drug testing technology. These upgrades include enhanced encrypted identification tags to ensure test integrity and improved firmware safeguards that allow only authorized updates and protect against cyber threats.

"Successful completion of penetration testing is another key milestone in our FDA 510(k) submission process. This independent assessment identified no major security vulnerabilities, confirming the effectiveness of our security approach,” said Harry Simeonidis, President and CEO at INBS. “These new upgrades reflect our commitment to protecting donor data and implementing security measures that meet and exceed regulatory expectations, bolstering our upcoming 510(k) submission to the FDA."

The penetration testing forms part of INBS's FDA 510(k) submission. By addressing security requirements early in the process, INBS is positioning its technology to meet evolving FDA guidance on medical device cybersecurity. If obtained, FDA clearance will open new revenue and expansion opportunities for the Company in the multi-billion-dollar U.S. drug screening market.

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, and involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, statements regarding Intelligent Bio Solutions Inc.’s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefits from its partnerships and collaborations, and secure regulatory clearance or 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, actual results may differ materially from those expressed or implied by such 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,” and “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, including those described in Intelligent Bio Solutions’ public filings with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of the date of this release. 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.
[email protected]

Investor & Media Contact
Valter Pinto, Managing Director
KCSA Strategic Communications
PH: (212) 896-1254
[email protected]


Risks

  • Regulatory approval from the FDA is not guaranteed and delays or denials could impact business prospects.
  • Market adoption risks exist as success depends on acceptance by employers in safety-critical industries and drug screening organizations.
  • Potential cyber threats or future security vulnerabilities might arise despite current security measures, affecting company credibility and regulatory status.

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