Latest Medical Devices News

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.

Imricor Medical Systems has secured Institutional Review Board approval for the University of Virginia Health to join its VISABL-AFL clinical trial, marking a key expansion in the US. Procedures are set to begin early next year, supporting Imricor’s progress toward FDA approval and commercialisation.

EBR Systems has completed the first patient implant in its Totally Leadless CRT (TLC-AU) feasibility study, marking a strategic step toward expanding wireless cardiac resynchronisation therapy for heart failure patients.

EBR Systems has expanded its intellectual property holdings with four new patents, reinforcing its lead in wireless cardiac pacing technology, while facing a preliminary setback on a patent term extension application.