Latest Clinical Validation News

PainChek Ltd has achieved a pivotal FDA De Novo clearance for its AI-driven Adult pain assessment app, unlocking the US market and driving its annual recurring revenue to $5.6 million. The company also launched its Infant app, targeting a vast global market of pre-verbal children.

Nova Eye Medical reported a robust 32% increase in global sales excluding China for Q1 FY26 and secured regulatory approval for its iTrack™ Advance device in China, setting the stage for expanded market penetration.

Echo IQ Limited has advanced its EchoSolv heart failure solution towards FDA submission, driven by a landmark clinical validation study and a sharp rise in US platform adoption. Strategic partnerships and international expansion efforts underscore the company’s growing footprint in cardiology AI.

4DMedical Limited has secured FDA clearance and immediate Medicare reimbursement for its groundbreaking CT – VQ™ lung imaging technology, accelerating commercial adoption across the US, Brazil, and Australia.

CONNEQT Health reports robust 50% quarter-on-quarter growth in Pulse device sales and launches a new pricing strategy to boost recurring revenue. The company also secures a significant US clinical trial contract and advances cost-cutting efforts.

SomnoMed reports a strong start to FY26 with 13.5% revenue growth and confirms the Clayton Sleep Institute as the first US site for its pivotal Rest Assure clinical study, backed by FDA protocol agreement.

Rhythm Biosciences reports strong Q1 FY26 progress, securing strategic partnerships and advancing commercial readiness for its ColoSTAT® colorectal cancer test alongside robust growth in its geneType platform.

INOVIQ Limited has raised $9.5 million to advance its pioneering ovarian cancer screening test and CAR-exosome therapeutic programs, backed by strong preclinical data and strategic partnerships.

LTR Pharma has made significant strides towards its US market debut with ROXUS, bolstered by expert appointments and peer-reviewed clinical data validating its rapid-onset ED treatments.

Arovella Therapeutics has secured encouraging feedback from the US FDA on reagent testing for its CAR-iNKT cell therapy, setting the stage for an IND filing this quarter and clinical trials in early 2026.

Zelira Therapeutics has made significant progress in its HOPE 1 clinical trial program, completing a key FDA submission and securing a $650,000 non-dilutive R&D loan facility to support ongoing development and working capital needs.

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.