Initial Testing of the Novel RAPIDscan Autonomous 30-Second Ultrasound Imaging Device

Introduction: Congenital heart defects effect about 1% of births, or 40,000 babies annually. Of these, about 1 in 4 have a critical defect, often requiring prompt diagnosis and intervention within the first hours of life. However, many remote and low resource hospitals do not have access to echocardiography required for diagnosis. A new medical device, the RAPIDscan autonomous 30-second ultrasound device, is being developed by Bloom Standard (Minneapolis, MN). In this study we conducted initial feasibility testing of multiple iterations of the RAPIDscan device. The RAPIDscan ultrasound device is designed for early detection of critical congenital heart disease in newborns and infants at hospitals without congenital heart programs.


Methods: We enrolled 22 patients admitted to the pediatric intensive care unit and cardiac intensive care unit at University of Minnesota Masonic Children’s Hospital from February 2024 to July 2025. Inclusion criteria were age < 12 months and a full echocardiogram within the past three months. Ultrasound images were obtained via RAPIDscan and compared to patient’s most recent full congenital ECHO. Two independent pediatric cardiologists reviewed the images and provided qualitative feedback using an anatomical checklist on image quality comparing the two images. Image quality and device feasibility data was collected with each scan and communicated to the engineering team, allowing them to iterate on the device multiple times during the study.


Results: A total of 22 RAPIDscan ultrasounds were obtained from patients with known congenital heart disease. Approximately half were of sufficient quality for the reading cardiologists to rule out critical congenital heart disease. Image quality was affected by internal pacer wires and chest tubes and was consistently better in smaller patients. Image quality improved over multiple iterations of the device with the last several images taken comparing closely to the patients congenital ECHO images.


Conclusions: Critical congenital heart defects are a serious and potentially life-threatening condition often requiring prompt diagnosis and intervention. The RAPIDscan medical device shows significant potential as a solution for hospitals without fast access to a congenital ECHO team and equipment.