Latest Regulatory Certification News

CleanSpace's AGILE respirator has achieved AS/NZS 17420.2:2021 certification, paving the way for commercialisation in Australia and New Zealand alongside its recent European approval.

CleanSpace Holdings has achieved a major regulatory milestone with European EN 12941 certification for its new AGILE loose-fitting PAPR, positioning the company for growth in its largest market and preparing for imminent Australian approval.

Janus Electric has raised A$4.5 million through a discounted private placement, aiming to accelerate battery supply, truck production, and certification efforts across Australia and North America.

De.mem Limited has extended its growth streak with record quarterly cash receipts of approximately $10.4 million, a 31% increase year-on-year, alongside positive operating cash flow of $504,000 for the March 2026 quarter.

Structural Monitoring Systems Plc reported a 55% jump in quarterly free cash flow to $1.4 million and eliminated its bank debt by repaying a C$0.8 million term loan. The company also launched the MTP138 radio targeting offshore markets and secured key certifications for its avionics products.

Memphasys has lodged regulatory submissions for its Felix™ System in Australia and India, following CE Mark approval, while progressing UK market entry under the CE Mark transition framework.

Structural Monitoring Systems Plc reports a profitable December quarter with 40% revenue growth, driven by strong avionics sales and progress toward FAA certification of its CVM™ technology.

Bioxyne Limited reports a remarkable financial turnaround for FY2025, driven by a 217% revenue surge and its first significant profit, underpinned by expanded medicinal cannabis manufacturing and new supply contracts.

Optiscan Imaging Ltd has launched its first in-human breast cancer study and unveiled a new veterinary imaging device, while securing a key US collaboration to support FDA submissions.

Skin Elements Limited advances its proprietary SE Formula biotechnology with ECO-Nurture poised for commercial rollout in 2026, alongside progress in disinfectant and sunscreen product lines.

Singular Health has landed a pivotal $2 million US pilot contract with Provider Network Solutions and completed an $8 million capital raise, advancing its medical imaging platform’s regulatory and product development milestones.

Structural Monitoring Systems Plc (SMS) reported a breakout second half of FY25 with a $3.1 million profit after tax, driven by strong operational leverage and strategic growth in avionics. The company secured over US$1 million in new orders from CAL FIRE and advanced FAA certification for its innovative sensor technology.