Latest Medical Devices News

Tetratherix has inked a global exclusive distribution agreement with healthcare giant Henry Schein, paving the way for its first bone regeneration product, Tegenix, to enter major markets in 2026. Concurrently, the company has begun building an advanced manufacturing facility to meet expected global demand.

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.