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.

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.

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.

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.