Latest Fda Clearance News

CurveBeam AI Limited has secured A$6.5 million in new capital to fuel global growth of its HiRise™ weight-bearing CT scanner, deepen its partnership with orthopaedic giant Stryker, and advance a potential strategic deal in China.

CurveBeam AI has secured A$6.5 million through an institutional placement and completed a €10 million vendor financing facility to accelerate sales of its HiRise™ CT scanner. The company is also progressing a strategic partnership in China and advancing surgical robot validation.

Echo IQ has completed its presentation to the CPT Editorial Panel for a Category III CPT code for EchoSolv AS, with a decision expected from the American Medical Association in the coming weeks. Meanwhile, the company is advancing US deployments and FDA clearance efforts.

Neurizon Therapeutics has raised $5 million through an institutional placement to advance its lead ALS drug candidate NUZ-001 into a pivotal clinical trial, pending FDA clearance. The capital injection also supports manufacturing and pre-clinical development efforts.

Artrya Limited has raised A$75 million through a two-tranche placement and launched a A$5 million share purchase plan to fast-track the U.S. commercialisation of its AI-powered Salix platform following FDA clearance.

4DMedical has secured multi-year agreements to deploy its advanced lung imaging technology across Brazil and Australia, supporting national lung cancer screening programs and enhancing lung health diagnostics.

Compumedics has secured FDA clearance for its single-use Somfit®D device, effectively doubling its addressable U.S. home sleep testing market to an estimated US$240 million annually. This milestone positions the company to capture significant market share with a dual-platform EEG-based solution.

4DMedical has won a crucial US Medicare reimbursement for its CT, VQ™ lung imaging software, paving the way for rapid adoption across American hospitals. This milestone follows FDA clearance and promises to transform lung diagnostics with safer, faster scans.

4DMedical Limited has secured FDA clearance for CT – VQ™, the first non-contrast CT-based ventilation-perfusion imaging technology, promising to transform lung diagnostics by replacing traditional nuclear scans.

Hydrix Limited narrowed its FY2025 loss to $2.92 million, driven by significant cost reductions and steady revenue from expanding international medtech clients. Despite ongoing challenges in sales cycles and funding, the company remains focused on innovation and strategic investments.

Orthocell Ltd reported a record $9.23 million revenue for FY25, driven by strong sales of its nerve repair and dental products, alongside securing US FDA clearance for its flagship nerve repair device Remplir. The company is poised for accelerated growth as it expands its global commercial footprint.

Echo IQ Limited reported a sharp increase in losses for FY25 despite revenue growth, while securing FDA clearance and expanding its AI-driven cardiology platform across major US networks.