Latest Medical Devices News

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.

Orthocell has reported a record $3.2 million in quarterly revenue, marking its seventh consecutive quarter of growth, driven by strong sales of its Remplir™ nerve repair product in Australia and early traction in the US market.

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.

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.

Orthocell has reached a significant milestone with 100 units of its nerve repair product Remplir™ sold in the US, signaling accelerating adoption in a $1.6 billion market. The company’s strategic medical education and distributor network are driving momentum ahead of further hospital approvals.

TrivarX Limited has reported compelling clinical trial results demonstrating its single-lead ECG algorithm’s high sensitivity in detecting major depressive episodes among US veterans, marking a significant step in objective mental health screening.

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.