Latest Medical Devices News

BlinkLab is advancing its FDA 510(k) clinical trials for autism and ADHD diagnostics, completing its U.S. autism pilot phase and expanding European ADHD recruitment. A recent $7.66 million capital raise supports these efforts as the company targets regulatory approvals in 2026.

Adherium Limited has appointed seasoned medtech executive Dawn Bitz as CEO to spearhead the expansion of its Hailie® respiratory monitoring platform, with a strong focus on the US market.

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.

dorsaVi reports transformative performance improvements from integrating RRAM technology into its biomedical sensor platforms, promising faster, more durable, and energy-efficient wearable devices.

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.

Amaero Ltd reports solid June quarter revenue and signs a pivotal five-year exclusive supply agreement with Velo3D, underpinning its growth outlook and updated EBITDA guidance for FY2027.

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.

AnteoTech Ltd has achieved a significant technical milestone with its 70% silicon Ultranode™ X anode, demonstrating nearly 900 cycles at 80% capacity retention, signaling a leap forward for electric vehicle battery performance and sustainability.

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.