Latest Clinical Adoption News

Optiscan Imaging Ltd has taken a significant step towards commercialising its InSpecta® veterinary imaging device in the US by submitting a regulatory dossier to the FDA. This milestone not only initiates formal review but also sets the stage for broader clinical adoption and future device approvals.

Aroa Biosurgery has completed its Symphony randomised controlled trial, demonstrating improved healing rates for diabetic foot ulcers compared to standard care. The preliminary results pave the way for clinical adoption and potential US reimbursement.

4DMedical has achieved CE Mark certification for its groundbreaking CT:VQ™ ventilation-perfusion imaging technology, unlocking the vast European market. The company also raised $83 million to fund rapid expansion across the EU.

4DMedical’s advanced lung imaging technology CT:VQ™ has been deployed at the Mayo Clinic, marking the sixth top US academic medical centre to adopt the system within seven months of FDA clearance.

Cleo Diagnostics has expanded its ovarian cancer biomarker panel from five to eight markers, enhancing test reliability and gearing up for FDA submission. A manufacturing deal is imminent, setting the stage for commercial rollout.

Memphasys Limited confirms uninterrupted operations across the Middle East and North Africa, securing new orders and advancing regulatory approvals despite ongoing regional tensions.

EBR Systems marked a pivotal transition in 2025 with FDA approval of its WiSE CRT System and the initiation of U.S. commercial implants, generating $1.6 million in revenue. Despite this progress, the company reported a net loss of $48.8 million and completed a significant capital raise to support ongoing growth.

BlinkLab has completed onboarding its tenth and final clinical site for its pivotal FDA 510(k) trial of an AI-powered autism diagnostic aid, setting the stage for patient enrolment to begin this month.

Rhythm Biosciences has achieved a significant regulatory milestone with NATA accreditation for its ColoSTAT® blood-based colorectal cancer test, enabling its commercial rollout in Australia and strengthening reimbursement prospects.

Entropy Neurodynamics reports a 14.8% reduction in half-year losses while progressing a pioneering clinical trial for Binge Eating Disorder using its proprietary psychedelic drug TRP-8803. The company also secured $6.1 million in new funding and strategic collaborations to enhance its neuropsychiatry platform.

Epiminder Limited has reported a $21.7 million loss for the half-year ending December 2025, alongside a successful $125 million IPO that fuels its commercialisation of the FDA-approved Minder epilepsy monitoring device.

OncoSil Medical has reported record dose sales and cash receipts in the first half of FY26, supported by encouraging clinical trial results and expanded European market penetration.