Latest Medical Devices News

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.

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.

ReNerve has inked an exclusive three-year deal with Hong Kong’s Swedish Trading Company to distribute its nerve repair products across a vast and dynamic healthcare region.

TruScreen Group reported a 42% increase in FY2026 sales driven by new market entries including India and Indonesia, alongside launching a large-scale cervical cancer screening program in Vietnam and submitting major UNITAID proposals.

OncoSil Medical has secured a pivotal ethics committee approval in Italy, reclassifying its OSPRItaly registry and enabling a streamlined procurement process that could double the number of authorised hospitals using its OncoSil™ device by mid-2027.

EMVision's First Responder Brain Scanner has proven its operational feasibility in aeromedical settings with the Royal Flying Doctor Service, de-risking rural stroke diagnosis and supporting progression to commercial production.

Osteopore has secured Hainan FDA approval to clinically use and sell its custom orthopaedic devices at Shanghai Ruijin Hospital’s Hainan branch, marking a key step towards wider China market access. The company has scheduled its first patient surgery for June 2026.

Aroa Biosurgery posted a breakout FY26, beating revenue and EBITDA guidance with a 54% surge in Myriad sales. The company plans significant investments in FY27 to accelerate growth and capitalise on new market opportunities.