Latest Medical Devices News

ParagonCare’s FY26 results show modest revenue and underlying earnings growth, overshadowed by a large credit loss provision related to the Infinity Pharmacy Group debt.

Epiminder Limited reported a $42.7 million loss for FY26, driven by clinical trial and product development costs following a $125 million IPO. The company progresses its FDA-approved Minder implantable EEG monitor with a pivotal US trial and next-gen device on track for 2028 launch.

PolyNovo reported a 16.1% rise in FY26 revenue to AUD 150 million, driven by strong global sales and manufacturing expansion, yet net profit fell 44% due to a significant asset write-off from an R&D centre fire and lower tax benefits.

Control Bionics has secured MHRA registration for its NeuroStrip device, unlocking commercial supply in Great Britain and launching early trials with leading UK institutions.

EMVision Medical Devices has made significant strides in its emu™ bedside scanner pivotal trial and First Responder program, boosting FY26 revenue by 57% while trimming its net loss by 15%.

Fisher & Paykel Healthcare has raised its full-year net profit guidance for FY2027, buoyed by robust first-half sales and a $23 million US tariff refund. The medical devices maker forecasts up to 24% profit growth in H1, driven by hospital product demand and operational efficiencies.

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.