Latest Clinical Adoption News

ImpediMed reported a $3.5 million revenue in Q3 FY26, with reimbursement coverage in the US reaching 94.3%, supporting growth in heart health and weight management markets. New CEO Erik Anderson aims to accelerate commercial momentum and drive cash flow break-even.

OncoSil Medical reported a 60% year-on-year increase in dose sales in Q3 FY26, boosted by expanding treatment centres and advancing clinical trials, while cost-cutting and a new manufacturing facility aim to underpin growth.

Singular Health boosted its US presence by deploying 500 additional 3DICOM MD® licenses to Provider Network Solutions, securing FDA 510(k) clearance for its cloud platform, and launching education pilots with Miami-Dade schools and Florida International University.

EBR Systems secures Priority Review from Australia's TGA for its wireless cardiac pacing system, fast-tracking regulatory approval and expanding access for heart failure patients. This follows strong US commercial momentum after FDA approval.

4DMedical lands a contract with pharma giant GSK, gains UKCA certification for its CT:VQ™ lung imaging technology, and joins the S&P/ASX 200, marking a significant step in its global expansion.

Memphasys Limited has marked a milestone quarter with revenue surpassing A$100,000, driven by repeat orders and multi-year contracts, signalling its transition to a commercially focused biotech business.

AVITA Medical’s Cohealyx-I study interim results show a significant acceleration in skin grafting time for full-thickness wounds, reducing mean time to graft from 33.2 to 13.6 days. The ongoing trial’s promising data could reshape wound care protocols.

Imricor Medical Systems has submitted its NorthStar Mapping System for FDA pediatric label expansion, aiming to accelerate adoption in over 250 US children’s hospitals and broaden its commercial footprint.

ImpediMed Limited has appointed Erik Anderson as its new CEO and Managing Director, effective 7 April 2026, aiming to boost commercial execution and revenue growth in the US market. Dr Parmjot Bains will remain as an advisor until 30 June 2026 to ensure a smooth leadership transition.

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.