Latest Us Market Entry News

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.

Janus Electric has begun generating export revenue in the US while expanding its electric truck fleet to 28 vehicles and significantly improving its cash position through a $1.4 million R&D tax refund and a $2.75 million finance facility.

LTR Pharma has wrapped up recruitment for its SPONTAN Phase II pharmacokinetic study, with interim results expected soon to bolster FDA approval efforts. Meanwhile, US commercial talks for ROXUS advance cautiously under the FDA 503(a) personalised medicine pathway.

Echo IQ has taken a major step in its US expansion by deploying its AI-powered EchoSolv AS software at Mount Sinai Health System, one of America’s leading cardiovascular centres. This marks a key milestone in integrating AI into routine cardiology workflows at scale.

Imricor Medical Systems updates its SEC Form 10 with minor SEC-driven revisions as it pushes forward with FDA clearances and clinical trials, reporting a $25.3 million net loss in 2025 amid early-stage commercialisation.

The FDA has removed the postmarketing cardiac repolarization study requirement for Clinuvel's SCENESSE®, reflecting confidence in its long-term safety profile. This marks a regulatory milestone for the only approved treatment for erythropoietic protoporphyria in the US.