BURL Concepts’ FOQUS™ System Completes First Human Uses for PFO Detection in Europe

BURL Concepts, a private MedTech company, announced the first clinical uses of its FOQUS™ ultrasound system, powered by SONAS® technology, for detecting brain emboli and evaluating patent foramen ovale (PFO) in patients across the Netherlands and the UK. The system introduces a rapid, automated approach to assessing cerebral blood flow that aims to simplify and expand access to PFO diagnosis.

During the procedures, clinicians used standard bubble test protocols by injecting a saline and oxygen microbubble solution intravenously. The FOQUS system monitored the entire brain transcranially for the passage of microbubbles—a sign of right-to-left cardiac shunting typically caused by a PFO, an opening between the heart’s atria that fails to close after birth. PFO is present in 40 to 50 percent of patients who have experienced a cryptogenic stroke.

The FOQUS test is designed to be completed in about 40 seconds without the need for sedation. Its automated design allows a single nurse to administer the test in outpatient settings without the support of a cardiologist or anesthesiologist, making it suitable for physician offices and diagnostic clinics.

Dr. Martin Swaans, a cardiologist at St. Antonius Ziekenhuis in Nieuwegein, Netherlands, noted that the system is already showing clinical utility. “FOQUS allows me to rapidly and easily test my patients for the presence of bubble emboli as part of a PFO evaluation,” he said. “By simplifying and accelerating testing, we can identify appropriate candidates for PFO closure more efficiently and reduce the risk of recurrent strokes in cryptogenic stroke patients.”

In the UK, cardiologists are also integrating FOQUS into patient care. Dr. Nick Palmer, consultant cardiologist at The Liverpool Heart and Chest Hospital, said the successful introduction of the non-invasive, nurse-operated test will help streamline diagnostic workflows. “Since the test can be performed by a nurse using standard bubble test techniques, I believe FOQUS will allow us to speed up testing and reduce local waiting lists,” he said.

The FOQUS platform includes a transcranial ultrasound headset and leverages SONAS technology to generate real-time brain perfusion data. According to BURL Concepts, this approach could help fill the diagnostic gap between invasive hospital-based tests and patients in community care settings who may face long wait times or limited access.

“Just as cardiac arrhythmia testing shifted from hospitals to outpatient settings, FOQUS has the potential to significantly expand access to PFO testing,” said BURL Concepts CEO Peter van der Sluis. “By enabling rapid, automated testing at the point of care, FOQUS allows physicians to efficiently evaluate more patients and identify individuals earlier who may benefit from a PFO closure device.”

The company plans to launch the FOQUS system in both the U.S. and European markets later this year.