BURL Concepts’ FOQUS System Achieves First Human Use, Paving Way for Scalable PFO Testing in Europe and Beyond

New updates have been reported about BURL Concepts.

BURL Concepts has completed the first human uses of its FOQUS ultrasound system for patent foramen ovale (PFO) detection in the Netherlands and the UK, marking a significant milestone in the company’s commercialization strategy for rapid, automated brain emboli testing. Using standard bubble test techniques with saline and oxygen microbubbles, FOQUS scans the entire brain in about 40 seconds to detect the characteristic “curtain” of bubbles that signals a PFO, a heart defect present in a large share of cryptogenic stroke patients. Initial clinical experience includes successful identification of PFOs in 30 patients across both countries, demonstrating that the system can deliver cardiology-grade diagnostic information with a non-invasive, transcranial headset that does not require sedation or on-site cardiologist or anesthesiologist support.

By enabling a single nurse to run the test in physician offices and diagnostic centers, FOQUS is designed to shift PFO evaluation away from hospital-centric workflows, potentially lowering costs, shortening diagnostic timelines, and expanding access in both urban and regional settings. European cardiologists involved in the early use report that the system can streamline triage for PFO closure procedures, help reduce waiting lists, and accelerate evaluation of large populations of cryptogenic stroke patients. BURL Concepts positions FOQUS, powered by its SONAS technology, as a scalable platform for brain perfusion assessment and emboli detection that could follow a similar adoption curve to cardiac arrhythmia testing migrating into outpatient environments. CEO Peter van der Sluis indicated the company plans to launch FOQUS in the US and Europe later this year, signaling an impending commercial phase in which reimbursement, clinical workflow integration, and regional distribution partnerships will likely be key determinants of growth and broader market impact.