Latest Medical Devices News

EBR Systems has launched the WiSE Coupler in the US, a new accessory designed to improve the implantation of its wireless cardiac pacing electrode. The device has FDA clearance and was piloted in 10 procedures, marking another step in the company’s US commercial expansion.

Resonance Health (ASX:RHT) closed FY26 with a net operating cash inflow of $2.9 million and completed recruitment for a $13.8 million clinical trial, underpinning a robust contract pipeline and growing net cash position.

PainChek has received a $1.123 million R&D tax incentive refund for FY2025, reinforcing its cash reserves and underpinning ongoing development of AI pain assessment algorithms and US market validation.

CONNEQT Health's June quarter saw record consumer revenue growth and a 70% jump in enterprise subscription ARR, supported by a $5.5 million placement and progress on its FDA regulatory pathway for its cloud-based vascular analytics platform.

Hydrix has landed a A$3.4 million contract with US-based Remedy Robotics to develop safety-critical software and embedded electronics for the N1 robotic system, marking a major step in its medical robotics ambitions.

Imricor Medical Systems has submitted its final 510(k) devices to the FDA, marking a major step towards commercialising its MRI-guided cardiac catheterisation platform in the US.

OncoSil Medical has gained Saudi FDA approval for its OncoSil™ device, enabling full reimbursement and commercial access in Saudi Arabia, the Middle East's largest healthcare market.

Marlin Global's portfolio delivered a 2.0% gross return in Q2 2026, driven by rebounds in ICON and semiconductor holdings, but lagged a strong US market rally led by AI and chip stocks.

Immuron Limited reported a 6% increase in FY26 sales to AUD 7.7 million, driven by strong gains in Canada and the US despite mixed Australian performance. Marketing initiatives and retail expansion underpin growth.

Advanced Engineered Materials has locked in an exclusive supply agreement with Swiss manufacturer Zürcher Frères, leveraging its nano particle high purity alumina to significantly enhance zirconia-alumina ceramics used in medical and industrial applications.

EMVision Medical Devices has hit key enrolment milestones in its pivotal brain scanner trial, expanded clinical endpoints, and maintained a strong cash position with $17.1 million on hand.

OncoSil Medical has completed key manufacturing validation cycles with Cyclotek, paving the way for scalable Australian production of its OncoSil™ device. With a $2.1 million capital investment, the company aims to boost margins and supply chain control ahead of commercial launch in late 2026.