Latest Us Commercial Rollout News

Artrya has converted its largest US customer and first SAPPHIRE Study participant into a five-year commercial agreement, while delaying its planned Coronary Flow FDA submission to strengthen clinical evidence. The Salix rollout is gaining traction, but revenue remains early and scan volumes are undisclosed.

Compumedics Limited (ASX:CMP) returned to profit in FY26 as record revenue, stronger cash generation and a sharp rise in MEG and SaaS sales reshaped its earnings profile. The company enters FY27 with A$28.3 million of open orders, but lower gross margins and uneven US and European execution remain key tests.

EBR Systems plans to file a Changes Being Effected PMA supplement in the fourth quarter to make echo-induced pacing risks and their mitigations more prominent on WiSE System labelling. The FDA has aligned with the proposed path, but the filing and final labelling changes are still ahead.

Singular Health Group lifted revenues over fivefold to $1.43 million in FY26, driven by US commercial rollouts of its 3DICOM platform, but posted a $6.34 million loss. The company strengthened its US foothold with FDA clearance and a controlling stake in an associate.

EBR Systems advanced its wireless cardiac pacing rollout in Q2 2026, completing 46 implants and signing 17 new purchasing contracts while shifting focus to deeper utilisation within existing accounts.

Epiminder has leveraged its $125 million IPO to advance clinical enrolments, boost Medicare reimbursement, and develop its next-generation Minder device, positioning for a commercial launch in early 2028.

Artrya is advancing its commercial footprint in the US with two health systems now generating revenue and FDA clearance for its Salix Coronary Flow module expected in H2 2026.

Echo IQ has locked in a strategic $20 million investment and US partnership with Pro Medicus, alongside a $110 million capital raise, positioning the company for accelerated commercial expansion of its AI-driven cardiovascular diagnostics in the US.

EBR Systems has launched the WiSE Coupler in the US, a new accessory designed to improve the implantation of its wireless cardiac pacing electrode. The device has FDA clearance and was piloted in 10 procedures, marking another step in the company’s US commercial expansion.

Orthocell Limited has posted record revenue for FY2026, driven by strong sales growth of Remplir™ and Striate+™ products in Australia, the US, and new international markets, supported by a robust $44.1 million cash position.

Echo IQ has raised approximately A$110 million through a heavily supported institutional placement to fund its US commercial rollout and speed up development of its AI-driven cardiovascular diagnostics.

EBR Systems has kicked off a fully underwritten 1-for-2 entitlement offer priced at $0.38 per CDI, aiming to raise $85.6 million to accelerate commercialisation and manufacturing of its wireless cardiac pacing technology.