Latest Us Reimbursement News

ImpediMed has secured A$15.2 million through a two-tranche placement and share purchase plan, alongside A$5 million in cost reductions, aiming for operating cashflow breakeven by H2 FY28.

ImpediMed reported a $3.5 million revenue in Q3 FY26, with reimbursement coverage in the US reaching 94.3%, supporting growth in heart health and weight management markets. New CEO Erik Anderson aims to accelerate commercial momentum and drive cash flow break-even.

Proteomics International is pivoting from research to disciplined commercial execution of its proteomics-based diagnostic tests, focusing on distributor partnerships and reimbursement pathways in Australia and the US.

4DMedical lands a contract with pharma giant GSK, gains UKCA certification for its CT:VQ™ lung imaging technology, and joins the S&P/ASX 200, marking a significant step in its global expansion.

Aroa Biosurgery has completed its Symphony randomised controlled trial, demonstrating improved healing rates for diabetic foot ulcers compared to standard care. The preliminary results pave the way for clinical adoption and potential US reimbursement.

PainChek Limited reported a half-year loss of AUD 4.7 million but achieved a major regulatory milestone with FDA clearance for its Adult App, unlocking significant US market opportunities. The company also completed a share consolidation and raised capital to support growth.

PainChek has secured FDA-regulated medical device status, enabling US Remote Therapeutic Monitoring reimbursement and opening a major US growth avenue. The company targets musculoskeletal pain management in non-verbal dementia patients, a largely underserved market.

Control Bionics reports a strong start to FY26 with nearly 10% revenue growth, expanded US reimbursement coverage, and advancing commercialization of its NeuroNode and NeuroStrip technologies.

Proteomics International Laboratories has secured ISO 15189 certification and launched PromarkerD and PromarkerEso nationally in Australia, while advancing US reimbursement pathways and preparing for leadership transition.

Echo IQ’s application for a Category III CPT code was declined by the AMA, but the company is exploring reconsideration and new AI-specific coding frameworks to advance US reimbursement.

Telix Pharmaceuticals secures Transitional Pass-Through payment status for its next-generation prostate cancer imaging agent Gozellix, paving the way for broader US patient access and streamlined provider reimbursement.

PolyNovo’s NovoSorb BTM, combined with negative pressure wound therapy, significantly accelerates healing of large post-surgical diabetic foot wounds, according to new clinical trial data.