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.

Adherium Limited has exceeded its 2025 shipment goals by delivering over 4,600 Hailie® Smartinhaler® devices, including more than 2,000 to Remote Patient Monitoring patients, signaling robust operational momentum.

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.

Telix Pharmaceuticals confirms completion of Part 1 enrolment in its ProstACT Phase 3 trial for prostate cancer, with safety data supporting progression to Part 2 and regulatory approvals secured across multiple countries.

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.

ECS Botanics is strategically preparing for entry into the US medicinal cannabis market, leveraging its EU-GMP certification and proprietary genetics amid evolving regulatory landscapes.

4DMedical has gained Canadian regulatory approval for its innovative CT – VQ™ ventilation-perfusion imaging technology, enabling immediate commercial rollout through Philips and expanding its North American footprint.

Orthocell has lodged a regulatory application to distribute its nerve repair product Remplir™ across the EU and UK, aiming to tap into a $750 million market with approval expected by Q3 2026.

Echo IQ has formally lodged its FDA 510(k) submission for EchoSolv HF, an AI-driven heart failure diagnostic software validated by Mayo Clinic data, aiming to tap into a $60 billion US market.

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.