Latest Us Market News

EMVision Medical Devices has activated two additional key sites in its pivotal trial for the emu™ bedside brain scanner, advancing its path toward FDA clearance. These new sites join a growing network of leading stroke centres across the US and Australia.

ReNerve Limited has entered a strategic partnership with Berkeley Biologics to develop and commercialise two new tissue-based product ranges, aiming to expand its footprint in the US surgical market by the end of 2025.

Lumos Diagnostics has reached 50% recruitment of bacterial positive patients in its pivotal FebriDx CLIA waiver clinical study, setting the stage for a planned FDA submission in late 2025 and unlocking a substantial US market opportunity.

Pacific Edge Limited has launched a NZ$20 million capital raise to bolster its cash reserves amid the loss of Medicare coverage for its bladder cancer diagnostic tests, aiming to accelerate US market adoption and support new product development.

Lumos Diagnostics has secured Medicare reimbursement for its FebriDx test from a sixth Medicare Administrative Contractor, covering over 85% of US Medicare payment regions. This milestone advances the company’s commercialisation efforts in the US healthcare market.

PainChek Limited has secured a pivotal reseller and integration deal with Eldermark Software, positioning its AI-driven pain assessment app for a major US market rollout pending FDA approval.

Straker Ltd has reported a record adjusted EBITDA of NZ$4.8 million for FY25, driven by strong growth in AI subscription services and operational efficiencies, even as overall revenue declined 10.3%. The company’s strategic pivot towards AI-powered offerings signals a promising shift in its business model.

4DMedical has submitted its CT:VQ™ software to the FDA, aiming to revolutionize lung ventilation and perfusion imaging by replacing traditional nuclear scans with a non-contrast CT-based solution.

Origin Energy has refined its FY25 earnings forecast, buoyed by strong wholesale performance but tempered by Octopus Energy's UK weather-related losses. Despite setbacks, Octopus continues to expand its retail footprint.

3P Learning forecasts steady revenue for FY25 but anticipates a significant 20% uplift in underlying EBITDA and a stronger net cash position, driven by strategic product expansions.

Fintech Chain Limited has applied to delist from the ASX, citing low valuation, poor liquidity, and high costs, aiming to unlock growth capital in China and the US.

Smart Parking Limited reports robust H1 FY25 growth driven by a strategic US acquisition and expanding global footprint, underpinned by proprietary AI technology.