Latest Medical Device Innovation News

Micro-X Ltd has secured a $4.4 million Australian Government grant to develop and trial a portable Head CT scanner designed for standard ambulances, aiming to transform emergency stroke care with faster diagnosis and treatment.

EBR Systems has secured final CMS approval for Transitional Pass-Through reimbursement for its WiSE CRT System, effective October 1, 2025, enhancing hospital adoption prospects in the U.S.

Atomo Diagnostics reported a 27% reduction in net loss to AUD 4.97 million for FY25, alongside a 7% revenue dip to AUD 3.79 million, driven by stronger margins and cost controls. The company also secured a significant US distribution contract through partner Lumos Diagnostics, positioning it for growth.

Compumedics has reported record-breaking sales orders and revenues for FY25, driven by strong US market growth and SaaS adoption, setting the stage for an ambitious FY26 expansion.

ReNerve Limited has achieved a key milestone with its first sale and clinical use of a deep dermal tissue product in the US, broadening its surgical applications beyond nerve repair. This move complements its existing nerve repair portfolio and sets the stage for further product launches later this year.

EBR Systems has secured FDA approval for its pioneering leadless WiSE CRT System and obtained key Medicare reimbursement endorsements, setting the stage for its commercial rollout. The company also completed a significant capital raise to support its market expansion.

EBR Systems has won final CMS approval for New Technology Add-On Payment reimbursement, paving the way for Medicare coverage of its innovative WiSE cardiac pacing system starting October 2025.

Optiscan Imaging Ltd has launched its first in-human breast cancer study and unveiled a new veterinary imaging device, while securing a key US collaboration to support FDA submissions.

PainChek has completed its final FDA submission for the PainChek Adult App, targeting the US long-term care market with a potential $100 million annual opportunity. A regulatory decision is expected within 75 days, setting the stage for rapid commercialisation.

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.

EBR Systems has successfully completed a heavily oversubscribed Security Purchase Plan, raising a total of A$75.9 million alongside a prior institutional placement to fund its innovative wireless cardiac pacing technology through 2027.

EBR Systems has completed the first commercial US implants of its FDA-approved WiSE wireless cardiac resynchronization therapy system, marking a pivotal step toward broader market adoption and reimbursement.