Latest Medical Devices News

Tissue Repair advances its US Phase III chronic wound trial with 100 patients randomised and targets October FDA 510(k) submission. The company reports a robust cash position bolstered by R&D refunds and has cut manufacturing scale-up costs.

EBR Systems advanced its wireless cardiac pacing rollout in Q2 2026, completing 46 implants and signing 17 new purchasing contracts while shifting focus to deeper utilisation within existing accounts.

OncoSil Medical reported a 53% increase in unit sales and advanced key regulatory approvals, including FDA final review and TGA listing, positioning it for growth in pancreatic cancer treatment.

Epiminder has leveraged its $125 million IPO to advance clinical enrolments, boost Medicare reimbursement, and develop its next-generation Minder device, positioning for a commercial launch in early 2028.

PainChek lifted implemented ARR by 5.9% to $4.46 million and secured its first US commercial contracts under a major Sabra REIT agreement, boosting customer receipts 27% in the June quarter.

ReNerve Limited delivered its strongest sales quarter ever with $211,000 in revenue, boosted by new distribution deals in Asia-Pacific and a $5 million funding facility to underpin growth.

Saluda Medical capped FY26 with a 28% revenue surge, beating guidance at US$90.2 million, while FDA approval for its CAP24 paddle lead opens a new US surgical market segment.

Vitrafy Life Sciences reported a breakthrough 94.4% post-thaw platelet recovery in US Army Phase II testing, secured major US blood network partnerships, and raised $32 million to accelerate US expansion and device manufacturing.

Adherium Limited has posted a fourth consecutive quarter of record remote patient monitoring revenue, driven by growing device activations and strong clinical evidence from the iCARE study, positioning the company for expanded value-based care contracts in the US.

Echo IQ has locked in a strategic $20 million investment and US partnership with Pro Medicus, alongside a $110 million capital raise, positioning the company for accelerated commercial expansion of its AI-driven cardiovascular diagnostics in the US.

Imricor Medical Systems has officially launched its US commercial operations, securing Rady Children’s Hospital–San Diego as the first customer for its NorthStar iMR mapping system, following key FDA clearances including pediatric approvals.

Adherium reports a near tenfold surge in recurring revenue from remote patient monitoring and clinical evidence supporting significant cost reductions in respiratory care.