Latest Medical Devices News

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.

Fisher & Paykel Healthcare has updated its dividend announcement to include the Australian Dollar equivalent, providing clearer insight for investors ahead of the mid-December payment.

Orthocell has achieved its first commercial sales of Remplir™ in Hong Kong, marking a pivotal step in its Asian growth strategy and expanding its footprint across key global markets.

Anteris Technologies has secured regulatory green lights for its pivotal PARADIGM trial and raised $25.2 million in capital, advancing its innovative DurAVR® transcatheter heart valve towards commercialisation.

BTC Health has reissued its Chairman’s Address with added financial details, highlighting a strategic shift towards diversified medical products and a strong start to FY26 with 36% revenue growth.