Latest Us Healthcare Market News

Pro Medicus Limited’s U.S. subsidiary has locked in two significant 5-year contract renewals worth a combined minimum of A$40 million, reinforcing its position in the competitive medical imaging market.

Pro Medicus Limited has reported a stellar half-year performance with revenue up 28.4% and a surge in net profit, driven by major US contract wins and strategic investments.

Imricor Medical Systems has taken a significant step toward US market entry by submitting its Advantage-MR EP Recorder/Stimulator system for FDA 510(k) clearance, aiming to enhance MRI-guided cardiac procedures.

Orthocell Ltd reports steady progress in commercialising its nerve repair product Remplir in the US, with sales growth, expanded distributor networks, and manufacturing upgrades underpinning its path to profitability.

Adherium Limited has exceeded its 2025 shipment goals for its Hailie Smartinhaler devices, driven by rapid growth in remote patient monitoring activations and improved US Medicare reimbursement policies.

ReNerve Limited reported a robust 80% increase in quarterly sales driven by strong US market adoption and expanded hospital approvals. The company advances its nerve repair product pipeline with key regulatory milestones and a refreshed board.

PainChek has achieved FDA regulatory clearance enabling its device to qualify for US Remote Therapeutic Monitoring reimbursement, positioning the company for significant growth in the expanding US healthcare market. The company also reports strong global licence growth and a solid pipeline across multiple regions.

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.