Latest Medical Devices News

ReNerve Limited has secured market approval for its NervAlign® Nerve Cuff in Malaysia, marking a key milestone in its Asia-Pacific expansion strategy. This approval follows earlier clearances in Hong Kong and Thailand, positioning the company to tap into a growing regional nerve repair market.

Nova Eye Medical has reported a record US$6.1 million in sales for the December 2025 quarter, driven by strong US demand and a 24% annual growth rate that outpaces the industry.

ReNerve Limited has secured broader regulatory approval in Hong Kong for its NervAlign® Nerve Cuff, enabling access to both public and private hospitals and validating the device’s clinical benefits through independent review.

EBR Systems reported a doubling of WiSE System implants in Q4 FY2025 alongside the launch of key clinical studies and preliminary revenue guidance, signalling strong commercial and clinical momentum.

Imricor Medical Systems has achieved a major milestone with FDA clearance for its Vision-MR Diagnostic Catheter, paving the way for commercial sales in the US electrophysiology market.

Hydrix Limited’s subsidiary has landed a significant A$2.5 million contract to develop SynCardia’s next-generation fully implantable Total Artificial Heart, marking a major step in advanced cardiovascular technology.

CurveBeam AI has received official Chinese regulatory approval for a strategic $10 million investment from WEGO Orthopaedics, marking a major step in its expansion into Greater China. The initial $4 million tranche at a premium share price is expected imminently, underpinning a decade-long commercialisation deal.

Memphasys has secured CE Mark approval for its Felix™ sperm selection system, enabling full commercial rollout across Europe and activating multi-year contracts worth over A$1.3 million. This milestone signals the company’s transition into a revenue-scaling phase with global growth ambitions.

Saluda Medical has received CE certification for its EVA™ Sensing Technology, enabling commercialisation in Europe and recognition in Australia following prior FDA approval. This milestone sets the stage for a broader rollout of its personalised spinal cord stimulation therapy in early 2026.

Imricor Medical Systems has secured Charité University Hospital in Berlin as the second global site for its VISABL-VT clinical trial, marking a significant milestone in real-time MRI-guided cardiac ablation technology.

Epiminder Limited has settled a $15.77 million tax liability with the ATO related to historical R&D claims, freeing up $4.23 million from IPO proceeds for working capital.

CONNEQT Health’s Pulse arterial health monitor sales have outpaced expectations with over 200% growth in the December quarter, driven by efficient marketing and early subscription uptake.