Latest Us Market Entry News

Optiscan Imaging has lodged a US FDA 510(k) application for InVue, its precision surgery device designed to provide cellular-level imaging during operations. The submission moves the technology into formal regulatory review, but clearance and commercialisation remain uncertain.

Imricor Medical Systems has reached a crucial milestone as the FDA accepts and closes the manufacturing module of its Premarket Approval submission, advancing its MR-guided electrophysiology devices closer to US market entry.

LTR Pharma is shifting gears from clinical trials to commercial rollout, securing US partnerships for ROXUS and reporting encouraging SPONTAN Phase II data that supports FDA approval ambitions.

Epiminder Limited reported a $42.7 million loss for FY26, driven by clinical trial and product development costs following a $125 million IPO. The company progresses its FDA-approved Minder implantable EEG monitor with a pivotal US trial and next-gen device on track for 2028 launch.

NeuroScientific Biopharmaceuticals posted a $4.69 million loss for FY2026, driven by R&D ramp-up and clinical progress with its StemSmart™ platform, while halting independent development of its glaucoma drug EmtinB to pursue licensing deals.

Medical Developments International (ASX:MVP) reported a 9% revenue increase to $42.6 million and a 566% jump in net profit to $0.6 million for FY26, driven by robust growth in its Pain Management segment and expanded paediatric approvals in Europe.

OncoSil Medical has won FDA Humanitarian Device Exemption approval for its OncoSil™ device to treat distal cholangiocarcinoma, opening a US market estimated at A$80 million annually.

Nodestream has engaged Waypoint Strategic Partners to provide hands-on leadership and operational support for its US market entry, marking a shift from assessment to active execution under its Plan Consilience defence strategy.

KTEK Aerosystems has obtained a key export licence from the Netherlands, enabling it to ship components to its US facility for assembly and delivery. This milestone solidifies the company’s trans-Atlantic supply chain and supports its targeted September delivery restart.

AdAlta’s lead CAR-T therapy EW-001 continues to demonstrate encouraging survival and response rates in its mesothelioma study, with all patients alive at the latest follow-up and stronger outcomes at higher doses supporting plans for an Australian Phase 1 trial.

Omnia Metals has made a strategic leap into the US critical minerals market by acquiring the Stibnite Ridge antimony and silver project and directly staking the Radix rare earth and gallium project in Montana. Supported by a $1.5 million placement, the company completed maiden field programs and secured key assay results that set the stage for follow-up exploration.

OncoSil Medical reported a 53% increase in unit sales and advanced key regulatory approvals, including FDA final review and TGA listing, positioning it for growth in pancreatic cancer treatment.