Latest Us Healthcare Market News

PainChek has secured FDA De Novo clearance, enabling entry into the vast US healthcare market with a $3 billion Remote Therapeutic Monitoring opportunity. The company reports $5.6 million contracted ARR and a strong global footprint in aged care.

Epiminder Limited has successfully listed on the ASX, raising $125 million to commercialise its FDA-approved Minder device. The company has initiated the first US implant and secured five leading medical centres for its DETECT study.

Cyclopharm’s Technegas has been recognised as the preferred ventilation agent in a pivotal draft US lung imaging guideline, signalling a major boost for its adoption in American clinical practice.

Echo IQ has completed clinical validation of its EchoSolv HF heart failure detection software with the Mayo Clinic Platform, achieving outstanding accuracy. The company has now formally submitted its FDA 510(k) clearance application, positioning itself for significant commercial expansion in the US healthcare market.

Vitasora Health has completed an A$11 million capital raise, including a cornerstone investment, bolstering its balance sheet to support ambitious growth in the US healthcare market. The company targets cash flow breakeven by the end of FY2026 amid expanding patient programs and new partnerships.

Oneview Healthcare reported a stronger cash position in Q4 2025 alongside a key expansion of its US footprint through a new partnership with a Top 10 health system. The company’s strategic moves set the stage for growth in 2026.

Proteomics International has secured a US patent for its PromarkerEso blood test, a pioneering diagnostic tool for early detection of esophageal adenocarcinoma, marking a critical step toward commercialisation in the world’s largest healthcare market.

Echo IQ has formally lodged its FDA 510(k) submission for EchoSolv HF, an AI-driven heart failure diagnostic software validated by Mayo Clinic data, aiming to tap into a $60 billion US market.

4DMedical secures a key clinical adoption milestone as the University of Miami begins using its CT – VQ™ respiratory imaging technology, following Stanford’s lead. Meanwhile, Lahey Hospital inks a two-year deal for IQ-UIP™, underscoring growing traction in US academic medical centers.

Vitasora Health has secured AU$3.56 million from a cornerstone investor, issuing over 118 million shares, while confirming compliance with key regulatory disclosure obligations.

Oneview Healthcare reported robust commercial growth in 2025, driven by new US client wins and the launch of its AI-powered care assistant, Ovie. The company enters 2026 with a confident outlook focused on expanding its US footprint and advancing digital health innovation.

Uscom Limited reported a 25% revenue decline in FY25 amid global geopolitical challenges but reinforced its commitment to growth through strategic partnerships and innovative medical technologies.