Latest Us Market Entry News

BCAL Diagnostics has strengthened its leadership, advanced breast cancer detection tests, and secured key funding and strategic investments to underpin its FY2027 growth plans.

LTR Pharma’s SPONTAN shows rapid absorption in Phase II interim data while securing key US commercial deals for ROXUS, setting the stage for a US market entry later this year.

Imricor Medical Systems has officially launched its US commercial operations, securing Rady Children’s Hospital–San Diego as the first customer for its NorthStar iMR mapping system, following key FDA clearances including pediatric approvals.

PainChek has received a $1.123 million R&D tax incentive refund for FY2025, reinforcing its cash reserves and underpinning ongoing development of AI pain assessment algorithms and US market validation.

Noxopharm reported significant progress in its Sofra technology, highlighting enhanced cancer drug potential and preparations for a US FDA clinical trial, while managing tight cash reserves.

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.