Latest Us Commercialisation News

Imricor Medical Systems has submitted its NorthStar Mapping System for FDA pediatric label expansion, aiming to accelerate adoption in over 250 US children’s hospitals and broaden its commercial footprint.

Artrya Limited reported a 44% increase in its half-year loss to $10.7 million as it transitioned from development to commercial operations in the US, securing FDA clearance and signing three foundation customers. An $80 million capital raise underpins its ambitious US expansion and ongoing product development.

4DMedical Limited has responded to ASX queries over its announcements of commercial agreements with leading US academic medical centres, clarifying its disclosure approach and denying ramping allegations ahead of a $150 million capital raise.

4DMedical Limited has raised AU$150 million to accelerate the commercial rollout of its FDA-cleared CT, VQ lung imaging technology in the US, leveraging a strategic partnership with Philips. This funding aims to expand adoption across major medical centres and government healthcare programs.

4DMedical Limited has raised $150 million through a well-supported institutional placement to accelerate the commercialisation of its innovative lung imaging product CT – VQ™ in the US market. The capital raise comes with minimal dilution and increased insider confidence.

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.

Orthocell has raised $30 million through an institutional placement to accelerate the US commercialisation of its flagship nerve repair product Remplir and expand its regenerative medicine portfolio.

Orthocell Limited has reported a record $3 million quarterly revenue, driven by strong sales of its nerve repair product Remplir in Australia and Singapore, while advancing its rollout in the US and Canada ahead of schedule.

Silex Systems has raised $130 million through an institutional placement to advance its SILEX uranium enrichment technology in the US, bolstering its financial position through FY2028.

Echo IQ has secured a strategic collaboration with the Mayo Clinic Platform and raised $17.3 million, advancing its AI-driven cardiology tools towards FDA clearance and US commercial scale.

Echo IQ has secured a pivotal reseller agreement with US-based SARC MedIQ, unlocking access to over 300 healthcare facilities and accelerating adoption of its AI-driven EchoSolv AS technology across the American cardiology landscape.

Echo IQ’s application for a key US procedural code was rejected but the company plans a swift resubmission, maintaining confidence in its US commercial rollout.