Latest Medical Devices News

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.

Control Bionics advances its neural-signal technology across assistive communication, sports, and medical sectors, securing key US reimbursement and distribution agreements while broadening its international footprint.

ImpediMed has revamped its leadership with two new commercial roles and reported encouraging sales momentum for its SOZO device. The company is advancing clinical trials and expanding its presence in cancer survivorship, weight management, and heart health sectors.

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.