Latest Regulatory Certification News

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.

archTIS Limited has secured A$7.5 million through a discounted share placement to fund expansion in the U.S. defence sector, deepen strategic partnerships, and accelerate product innovation focused on secure data collaboration.

Proteomics International has published clinical validation results for PromarkerEso, a novel blood test that detects esophageal adenocarcinoma with remarkable accuracy, promising a non-invasive alternative to costly and uncomfortable endoscopy procedures.

Memphasys has completed the final patient visit in its Felix™ clinical trial, with data lock expected within two weeks and preliminary results slated for early March 2025. This milestone paves the way for CE Mark submission and imminent commercialisation in Europe.

Structural Monitoring Systems plc has raised $8.7 million and implemented a major cost restructuring, positioning itself for profitable growth with strong sales momentum in its avionics and sensor technology segments.