Shares of Intelligent Bio Solutions Inc. (NASDAQ:INBS) are surging Monday afternoon after the medical technology company announced a significant regulatory milestone for its rapid testing unit.
- Intelligent Bio Solutions stock is showing exceptional strength. Why is INBS stock up today?
Strategic Alignment with FDA Standards
The company revealed that its Intelligent Fingerprinting Drug Screening business successfully secured recertification to the ISO 13485:2016 quality management system standard.
Issued by the British Standards Institution, the three-year recertification becomes effective October 14. The milestone directly supports the company’s broader U.S. regulatory push, following the FDA’s recent adoption of ISO 13485:2016 into its updated Quality Management System Regulation.
Intelligent Bio Solutions operates an FDA-registered facility in the U.K., and this alignment provides vital structural support as it actively pursues U.S. FDA clearance for its non-invasive fingerprint sweat drug screening system to detect codeine. Additionally, the company completed recertification to the ISO 9001:2015 standard.
Management Commentary on Regulatory Progress
“High-quality standards are something we take seriously at every level of the business,” said Callistus Sequeira, Vice President of Global Quality & Operations at Intelligent Bio Solutions.
“With the FDA’s Quality Management System Regulation now in effect and incorporating ISO 13485:2016, our existing certification and FDA-registered facility status mean the quality framework underpinning our operations is aligned with the standard at the core of the new regulation,” Sequeira added. “This directly supports our efforts to secure FDA clearance.”
INBS Shares Climb Monday Afternoon
INBS Price Action: Intelligent Bio Solutions shares were up 18.41% at $3.28 at the time of publication on Monday, according to Benzinga Pro data.
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