Latest Quality Management Systems News

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.

Cleo Diagnostics has successfully completed Stage 1 of the Medical Device Single Audit Program, marking a significant step toward FDA submission and global commercialisation of its ovarian cancer test.

Green Critical Minerals advances its Very High Density graphite technology with strong thermal performance validation, production scale-up, and strategic moves into global markets including a planned US listing.

BlinkLab Limited reported a substantial net loss of $5.7 million for FY2025, driven by intensive R&D and clinical trial activities, while securing $7.66 million in fresh capital to fuel its smartphone-based neurodevelopmental diagnostic platform targeting autism and ADHD.

Aurora Labs has advanced its micro gas turbine program with key test bench upgrades, a significant Defence grant, and strategic partnerships, positioning itself for international defence market entry.

OM Holdings Limited has reported Q1 2025 production in line with guidance, completed a significant refinancing, and highlighted ongoing operational trials amid evolving market conditions for ferrosilicon and manganese.