Latest Us Market Entry News

Optiscan Imaging has kicked off a US clinical trial with Mayo Clinic to test its InVue and InForm devices in breast conserving surgery, aiming to generate data for FDA 510(k) submissions and validate a new surgical-pathology workflow.

Imricor Medical Systems has submitted its final 510(k) devices to the FDA, marking a major step towards commercialising its MRI-guided cardiac catheterisation platform in the US.

LTR Pharma has locked in a comprehensive commercial agreement with Strive Pharmacy, cementing its manufacturing and fulfilment infrastructure for the upcoming US launch of ROXUS®.

LTR Pharma has formalised its US commercialisation strategy by signing a definitive agreement with telehealth leader Shed, targeting at least 150,000 ROXUS units in the first year through digital men’s health platforms.

Optiscan Imaging has begun commercial sales of its InSpecta™ microscopic imaging device in the US veterinary sector following FDA clearance, marking its first clinical device launch and a strategic expansion into a $15.87 billion market.

Imricor Medical Systems has submitted the third of four Premarket Approval modules to the FDA, marking a key step towards US approval of its MR-guided cardiac ablation devices.

OncoSil Medical has cleared a major regulatory hurdle as its Humanitarian Device Exemption application nears FDA approval, while its TRIPP-FFX trial shows promising results combining OncoSil with standard chemotherapy for pancreatic cancer.

LTR Pharma has secured a binding US telehealth commercialisation framework for its intranasal erectile dysfunction treatment ROXUS, committing to at least 150,000 prescriptions in the first year and granting exclusivity to Shed Holdings' platform.

GCM Corporation is seeking shareholder approval for a 15-to-1 share consolidation as a strategic step towards a potential listing on a US national stock exchange, aiming to boost international capital access and market visibility.

Smart Parking Limited grew its ANPR sites by 17% in Q3 FY26 and increased parking breach notices by 19%, leveraging acquisitions and AI technology to expand across Europe and New Zealand.

LTR Pharma highlights SPONTAN's 5x faster absorption and validated safety, backed by over 1,000 Australian prescriptions and strategic partnerships as it targets FDA approval and US market entry.

Peak Processing reported its first positive EBITDA month in March 2026, driven by operational efficiencies and strong production growth. The company upgraded its Q4 production forecast and expanded key customer contracts, signaling a turning point after a challenging period.