Latest Regulatory Certification News

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.

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.