Latest Medical Devices News

Cleo Diagnostics (ASX:COV) posted a 48% jump in annual loss to $5.9 million amid key progress in its ovarian cancer diagnostic test, including completion of a pivotal US trial and preparations for FDA 510(k) submission.

ReNerve Ltd (ASX:RNV) reported an 80% year-on-year revenue increase in Q4 FY26, backed by expanding product lines and a $5 million funding facility. The company is advancing FDA approvals and growing its global distribution footprint, targeting a rapidly expanding $6.19 billion nerve repair biomaterials market.

ImpediMed has secured FDA 510(k) clearance for its SOZO Digital Health Platform to assess sarcopenia risk, marking it as the only FDA-cleared bioimpedance spectroscopy solution for this clinical application. This clearance enables clinicians to non-invasively monitor muscle loss in cancer and chronic disease patients, potentially improving treatment outcomes.

AVITA Medical's PermeaDerm biosynthetic wound matrix delivers clinical outcomes on par with allograft while slashing treatment costs by 70%, according to a new multicenter study.

Cryosite Limited delivered robust FY26 results with revenue up 18% to $16.7 million and net profit rising 19%, underpinned by a strategic warehouse acquisition that doubled storage capacity and a cool room expansion.

Adherium has tapped its major shareholder, Trudell Medical, for a further AUD 1 million unsecured loan to bolster working capital, adding to a recent USD 1.65 million facility.

OncoSil Medical has won FDA Humanitarian Device Exemption approval for its OncoSil™ device to treat distal cholangiocarcinoma, opening a US market estimated at A$80 million annually.

ResMed Inc. posted a 10% rise in fiscal 2026 revenue to $5.65 billion, bolstered by the acquisition of Noctrix Health and an agreement to sell its MatrixCare business. The company continues to invest in AI-powered digital health solutions amid ongoing patent litigation and a shifting regulatory landscape.

Anteris Technologies posted a $51.7 million loss in H1 2026 amid ramped-up R&D and clinical trial activity, supported by a $320 million capital raise and Medicare reimbursement for its DurAVR heart valve trial.

EBR Systems marked a commercial milestone with over 100 WiSE CRT implants and secured purchasing agreements with three major US healthcare networks. The company is progressing toward Medicare coverage and scaling manufacturing, supported by a near-complete A$150 million capital raise.

ReNerve Limited has gained marketing approval for its flagship NervAlign Nerve Cuff in India, marking a critical milestone in its global expansion and enabling commercial rollout in one of the world's largest nerve repair markets.

Imricor Medical Systems has ignited its US commercial operations with rapid adoption by top pediatric hospitals, buoyed by FDA pediatric clearances and clinical trial progress.