Latest Medical Devices News

Vitrafy Life Sciences has secured A$30 million through an institutional placement to ramp up manufacturing of its Guardion cryopreservation devices and expand US sales operations, with an additional A$2 million sought via a shareholder plan.

TruScreen has secured clinical validation from the world’s largest cervical screening study in China, setting the stage for rapid market expansion across Asia, Africa, and Europe.

EBR Systems has kicked off a fully underwritten 1-for-2 entitlement offer priced at $0.38 per CDI, aiming to raise $85.6 million to accelerate commercialisation and manufacturing of its wireless cardiac pacing technology.

ReNerve has appointed J4 Biologics as a second manufacturer for its Empliq range to meet growing hospital approvals and market demand, strengthening its supply chain and scaling production capacity.

Imricor Medical Systems has submitted the third of four Premarket Approval modules to the FDA, marking a key step towards US approval of its MR-guided cardiac ablation devices.

Simble Solutions is on the cusp of revealing initial results from its NanoSensor technology development, targeting major markets including Industrial IoT, defence sensing, and wearable medical devices.

dorsaVi has secured exclusive rights to two key robotics patents from NTU Singapore, filling critical gaps in safety control and data acquisition to expand into collaborative robotics and exoskeleton markets.

OncoSil Medical has cleared a major regulatory hurdle as its Humanitarian Device Exemption application nears FDA approval, while its TRIPP-FFX trial shows promising results combining OncoSil with standard chemotherapy for pancreatic cancer.

Resonance Health is progressing its MRI Liver Fibrosis device through late-stage clinical validation, targeting FDA biomarker qualification, while maintaining a profitable SaaMD platform and forecasting $16 million revenue for FY26.

EBR Systems has secured A$106.4 million through a fully underwritten institutional placement and entitlement offer, positioning the company for further commercial expansion of its wireless cardiac pacing technology.

ReNerve Limited has appointed UG Medical to distribute its NervAlign nerve repair products in Malaysia, tapping into a fast-growing healthcare market backed by government investment.

EBR Systems has secured a significant regulatory milestone as the US Centers for Medicare & Medicaid Services (CMS) initiates a National Coverage Determination (NCD) for its WiSE wireless cardiac pacing system, aiming for approval by early 2027.