Latest Quality Management Systems News

OncoSil Medical has moved closer to local production after contract manufacturer Cyclotek secured ISO 13485 certification for its quality management system. Production at the Macquarie Park facility remains targeted for the end of 2Q FY27, subject to further regulatory approval.

Imricor Medical Systems has reached a crucial milestone as the FDA accepts and closes the manufacturing module of its Premarket Approval submission, advancing its MR-guided electrophysiology devices closer to US market entry.

Noumi Limited lifted FY26 revenue by 8.8% and adjusted operating EBITDA by 7.6%, driven by Dairy & Nutritionals' strong earnings and strategic investments in Plant-based Milks. The company faces refinancing uncertainty with $610 million convertible notes maturing in May 2027, prompting a proposed acquisition by majority shareholder Arrovest.

Atomo Diagnostics reported a 40% increase in FY26 revenue to $5.3 million, driven by a surge in HIV self-test sales and new OEM customer orders. The company is advancing its syphilis and liver test developments while enhancing manufacturing capacity.

PolyNovo has completed its pivotal US clinical trial report for NovoSorb BTM and adjusted its FDA Premarket Approval submission timeline to late 2026 to incorporate updated regulatory requirements and additional data.

Nexsen Limited has cleared a major FDA regulatory hurdle for its StrepSure rapid Group B Streptococcus test, confirmed a clear 510(k) submission pathway, and secured over A$1.7 million in non-dilutive grants to expand clinical validation and market rollout in Asia-Pacific and neonatal diagnostics.

Nexsen Limited (ASX:NXN) has completed its Stage 1 ISO 13485 audit, confirming its Quality Management System (QMS) supports clinical validation and regulatory submissions for its diagnostic products, including StrepSure®. The company is progressing toward full certification and alignment with MDSAP requirements to facilitate global market access.

Nyapiri Macro Mining, a majority Indigenous-owned mining services company, has locked in a multi-year framework agreement with BHP, promising streamlined operations and enhanced Indigenous participation at the Mt Goldsworthy site.

IperionX has completed commissioning of its titanium powder and component manufacturing facilities, setting the stage for a major production scale-up backed by US Department of War funding. The company is progressing commercial contracts and advancing its critical minerals project in Tennessee.

Optiscan Imaging Ltd has made significant strides in clinical studies and regulatory readiness, partnering with Australian Clinical Labs and launching new cancer imaging trials as it prepares for multiple FDA submissions in 2026.

Anteris Technologies Global Corp. has filed a Form S-1 registration statement with the SEC to enable resale of shares issued in a recent private placement, marking a key step in advancing its DurAVR transcatheter heart valve system and pivotal clinical trials.

Anteris Technologies Global Corp. reported a $22.2 million loss in Q3 2025 while progressing its DurAVR Transcatheter Heart Valve pivotal trial following key regulatory approvals. The company bolstered its cash position with a $25.2 million private placement post-quarter.