Bloom Standard Granted FDA Breakthrough Device Designation for EVA RAPIDscan Ultrasound System
Novel ‘self-driving’ ultrasound technology aims to aid clinicians in earlier identification of cardiac and cardiopulmonary conditions, starting with newborns and infants
December 7, 2023 — The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Bloom Standard’s eva (echo view automation) RAPIDscan Ultrasound System as a method to screen and monitor cardiac and cardiopulmonary conditions in newborns and infants. The novel ‘self-driving’ ultrasound technology can serve as a diagnostic aid to expedite and guide early clinical decision-making for at-risk babies, expanding access beyond traditional ultrasound imaging settings to reach vulnerable patients in their local communities of care.
One baby with CHD is born every 15 minutes in the United States. It is the most common and deadly birth defect, responsible for at least 10% of infant mortality. More than 90% of infants do not have immediate access to trained pediatric sonographers or echocardiographers to acquire ultrasound images, or the specialists required or interpret them. This can result in delayed medical intervention, unnecessary or multiple patient transports, increased medical costs, longer hospitalizations, poorer outcomes and increased mortality.
The FDA’s Breakthrough Device Designation is only granted to devices that represent a breakthrough in effective treatment or diagnosis of life-threatening or debilitating conditions, and to technologies where no approved or cleared alternative is currently available. The status was only granted to 166 devices last year, and means Bloom’s technology will undergo priority review and benefit from consistent communications with FDA that are designed to expedite market availability and patient access.
“Such good news that Bloom Standard has received Breakthrough Designation for its rapid automated ultrasound technology, as this affords their team the opportunity to work interactively with the FDA through the submissions, leveraging this priority review pathway and the additional resources provided by the Breakthrough Device Program,” said Kolaleh Eskandanian, Ph.D., MBA, vice president and chief innovation officer at Children’s National Hospital. “Recognizing the need, and the potential impact of this imaging device for the smallest, most vulnerable patients, we have supported Bloom’s team in moving this potentially lifesaving technology from concept stage through to clinical validation.”
“This designation is a significant milestone toward our goal of bringing a product that can greatly impact the timely identification and treatment of the youngest patients with congenital heart defects and pediatric cardiac conditions,” said Annamarie Saarinen, co-founder and CEO of Bloom Standard. “As the mother of a child diagnosed with “just in time” with heart defects as a newborn, this designation is both exciting and emotional. Working in our clinical partner sites, we see firsthand every day how ultrasound can save lives. But only if it’s accessible for babies and health staff on the front lines of care delivery. We look forward to continuing to work closely with the FDA through this process on the road to helping babies and children worldwide.”
“We’re so pleased Bloom Standard has received Breakthrough Designation for its innovative ultrasound device…Congenital and pediatric heart diseases are responsible for 10% of all infant mortality, and the largest birth-defect related killer of children around the world. Access to early detection and tools to monitor the status of those already diagnosed is a clear unmet need, especially for those children located far from higher levels of care or pediatric hospitals,” said Gwenyth Fischer, MD, director of the Pediatric Device Innovation Consortium, (PDIC) and pediatric critical care physician at University of Minnesota M Health Fairview Masonic Children's Hospital. “This team has worked diligently to tackle this crisis, and to highlight the disparities faced by the smallest, most vulnerable patients, who are often overlooked in medical device development.”
Bloom Standard’s flagship technology has benefited from clinical and technical support from several US-based Pediatric Device Consortia-affiliated (PDC) institutions, including Children’s National Medical Center, University of Minnesota M Health Fairview Masonic Children’s Hospital and Texas Children’s Hospital, from technical resources were provided through the Stanford Biodesign / Impact 1 program, and from the Swansea University Faculty of Medicine, Health and Life Science, Institute of Life Science (ILS), Health Technology Wales, Tritech Institute, and two NHS health boards. Multi-center clinical investigations are continuing across three continents, the largest of which has been conducted in collaboration with the Autonomous University of Queretaro, Queretaro Ministry of Health, and Hospital Infantil Federico Gomez, Mexico City, one of only three pediatric heart centers in Mexico.
ABOUT THE eva RAPIDscan ULTRASOUND SYSTEM
Bloom Standard’s eva RAPIDscan Ultrasound System is a completely automated, user-agnostic, non-invasive ultrasound screening tool specifically designed for neonatal and infant use, providing a rapid scan and clinical decision support on the front lines of care to earlier detect cardiac abnormalities and monitor cardiac status in the youngest patients.