Latest Medical Devices News

EBR Systems has received preliminary approval from the U.S. Centers for Medicare & Medicaid Services for outpatient reimbursement of its WiSE® CRT System, marking a major step toward broader hospital adoption.

Compumedics Limited has reported record sales orders and a return to profitability in FY25, setting the stage for robust growth in FY26 driven by US market traction and SaaS expansion.

Osteopore Limited has gained Swiss market approval for its 3D-printed bioresorbable implants under the EU Medical Device Regulation, completing its European product portfolio and strengthening its partnership with Zimmer Biomet.

Imricor Medical Systems has secured key European regulatory approvals for its second-generation NorthStar system and initiated its commercial launch, while US FDA submissions progress amid some delays.

Orthocell has achieved a significant milestone by recording its first US sales revenue for Remplir™, its flagship nerve repair product, shortly after FDA clearance and initial surgical use.

Vitasora Health has completed the first tranche of its $11 million capital raise, positioning the company to fund growth initiatives and reach cash flow breakeven in the second half of fiscal 2026.

Nova Eye Medical has reported a record A$28.8 million in revenues for FY25, driven by strong US sales and sustained growth of its flagship iTrack™ Advance device.

Argent BioPharma has begun supplying its EU-GMP cannabinoid API for drug-resistant epilepsy treatment at University Medical Centre Ljubljana, marking a key clinical and regulatory milestone in Europe.

dorsaVi has begun critical testing of its innovative RRAM-powered sensor systems in Singapore, targeting biomedical applications like EMG and ECG to enhance wearable device performance and energy efficiency.

Cochlear Limited has secured FDA approval for its latest Nucleus Nexa System and Kanso 3 sound processors, setting the stage for a US market debut in early FY26.

Nanosonics has launched trophon3, its next-generation ultrasound disinfection device, alongside a software upgrade for existing users, promising faster cycles and enhanced digital integration.

TruScreen Group Limited has corrected an administrative error in its Share Purchase Plan allocations, ensuring shareholders receive their proper pro-rata entitlements ahead of a key special meeting.