Latest Medical Devices News

PainChek Limited has raised A$7.5 million through a strongly supported placement to accelerate its US market entry following anticipated FDA clearance and expand its innovative AI pain assessment technology internationally.

Compumedics has secured two significant four-year distribution agreements in China worth A$24.4 million, reinforcing its strategic foothold in Asia with committed annual growth of at least 10%.

Imricor Medical Systems reported significant regulatory and commercial progress in Q2 CY25, including CE mark approvals and expanded clinical trials, while maintaining a strong cash position.

Universal Biosensors reports a $1.59 million improvement in operating cash outflows for Q2 2025, maintaining $2.55 million in cash as it advances commercialization across blood, wine, and water testing markets.

BTC Health has secured a $0.5 million order for its life-saving ECMO equipment from the Women's and Children's Hospital in Adelaide, marking a significant expansion of its specialised medical device network alongside Melbourne's Royal Children's Hospital.

Atomo Diagnostics has successfully placed $260,000 of the shortfall from its recent Share Purchase Plan, issuing over 14 million shares and options to sophisticated investors. This capital injection strengthens the company’s working capital position as it advances its rapid diagnostic test business.

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.

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.

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.