Bloom Standard
News
Winners Announced
More big news for little babies! Honored to be awarded by the Alliance for Pediatric Device Innovation (APDI), funded by the FDA Pediatric Device Consortia program with additional support from Additional Ventures for Bloom’s RAPIDscan autonomous ultrasound screening device. These funds will build on our FDA Breakthrough Device status, support our final sprint through to design lock and regulatory approvals.
FOR IMMEDIATE RELEASE
Bloom Standard
Joins Prestigious Mayo Clinic Platform_Accelerate Program
FDA Breakthrough ‘self-driving’ ultrasound technology aims to aid clinicians with
AI-enabled automation in image acquisition and analysis
Minneapolis, MN, Sept 9, 2024 – Mayo Clinic Platform_Accelerate announced today that Bloom Standard has joined its inaugural imaging cohort to further optimize its AI-based multimodal ultrasound screening platform.
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Based on a competitive selection process, Mayo Clinic Platform’s program offers selected AI healthcare cohorts access to its robust data science environment and state of the art analytics tools to build, train and optimize AI algorithms. Participating startups also have access to Mayo Clinic experts in regulatory, clinical, technology and business domains, with a focus on AI model validation, regulatory needs and clinical readiness.
Bloom Standard’s flagship RAPIDscan system is a 1-minute, autonomous ultrasound imaging scan for earlier detection, rapid assessment and monitoring of medical conditions in mothers, babies and children. Its initial suite of deep learning algorithms will help risk-stratify babies and children of risk of potentially life-threatening cardiac and cardiopulmonary conditions. The Mayo Clinic Platform_Accelerate program provides a secure environment that allows companies to build AI models they can use for innovation in a secure, privacy protecting environment where the data never leaves the Mayo Clinic Platform environment.
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“Being selected to join the Mayo Clinic Platform_Accelerate program is a significant milestone for Bloom Standard. Participating in Mayo’s prestigious program doesn’t just validate our efforts…it provides a springboard to the company’s next stage of growth,” said Annamarie Saarinen, CEO Bloom Standard. “Minutes matter for the patients we serve. We look forward to leveraging Mayo Clinic’s incredibly rich and secure data to further optimize and integrate our AI models, accelerate our regulatory pathway, and build on Bloom’s recent Breakthrough Device Designation from the U.S. FDA.”
Bloom Standard’s device can be operated by virtually any level of health staff, anywhere. RAPIDscan leverages EVA (Echo View Automation) AI algorithms for device “smart placement” and clinical decision support allowing the device to be operated by virtually any level of health staff, anywhere as a diagnostic aid, guiding triage and referral pathways on the front lines.
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The US Food and Drug Administration (FDA) granted Breakthrough Device Designation to Bloom Standard’s eva (echo view automation) RAPIDscan Ultrasound System as a novel breakthrough technology to provide rapid and essential information to aid in earlier detection and monitoring of heart and pulmonary conditions in neonatal and infant patients.
Greater than 90% of infants do not have immediate access to pediatric sonographers or the specialists required to acquire or interpret ultrasound images, which can result in delayed medical intervention, unnecessary or multiple patient transports, increased medical expenditures, longer lengths of hospitalization, additional procedures, and poorer health outcomes or even death.
Every 15 minutes in the U.S., a baby is born with Congenital Heart Disease (CHD), impacting approximately 1 to 2% of all newborns. Globally it is the most common cause of death in the first year of life with CHD accounting for up to 10% of all infant deaths and 40% of all deaths due to congenital malformations. Currently, only 100 echocardiography labs across the country are responsible for more than 2.5M pediatric cardiac ultrasounds (echocardiograms) each year, leaving most infants without immediate or even nearby access to essential ultrasound imaging services, particularly those in rural, underserved and community health settings.
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About Bloom Standard
Bloom Standard’s RAPIDscan self-driving ultrasound system is a user-agnostic, non-invasive ultrasound screening tool that consists of automated ultrasound hardware combined with AI-based clinical decision support software for rapid, actionable assessment on the front lines of care. Development has been supported by FDA-funded Pediatric Device Consortia (PDC) program, including Children’s National Medical Center, the Alliance for Pediatric Device Innovation, UCSF-Stanford Pediatric Device Consortium, University of Minnesota Pediatric Device Innovation Consortium, Stanford Biodesign / Impact 1 program and the Southwest National Pediatric Device Innovation Consortium (SW PDIC), Stanford Biodesign / Impact 1.
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About Mayo Clinic Platform
Founded on Mayo Clinic’s dedication to patient-centered care, Mayo Clinic Platform enables new knowledge, new solutions and new technologies through collaborations with health technology innovators to create a healthier world. To learn more about Platform_Accelerate, visit the Mayo Clinic Platform_Accelerate website.
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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and providing compassion, expertise and answers to everyone who needs healing.
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CONTACT:
Jacob Colvin
+1 801-244-9988
jake@bloomstandard.com
Bloom on social media:
https://www.linkedin.com/company/bloomstandard/ | https://x.com/bloomstandard
FOR IMMEDIATE RELEASE
Pediatric Emergency Medicine and Point of Care Ultrasound Expert Alyssa Abo, MD MBA Joins Bloom Standard as Chief Medical Officer
Novel ‘self-driving’ ultrasound technology aims to aid clinicians in earlier identification
of cardiac and cardiopulmonary conditions, starting with newborns and infants
Minneapolis, MN, May 20, 2024 – Bloom Standard, an innovator in automated ultrasound imaging devices, announced today the appointment of Dr. Alyssa Abo as its new Chief Medical Officer. Dr. Abo's appointment underscores Bloom Standard's commitment to enhancing its clinical leadership and expanding its reach to diverse healthcare settings across the globe.
Dr. Abo is a Harvard-trained physician-innovator with a background in bioengineering and over 20 years of experience at the intersection of technology, healthcare, and business. She's a trailblazer in clinical medicine, developing strategies and harnessing emerging technologies to redefine patient care. Renowned globally as a leader in point-of-care ultrasound (POCUS), her groundbreaking contributions advanced POCUS within Pediatric Emergency Medicine. Before joining Bloom Standard, Dr. Abo was a Professor of Pediatrics and Emergency Medicine at the George Washington University School of Medicine and Health Sciences. Notably, she was the first woman physician to achieve the rank of Full Professor in this specialty.
Dr. Abo has been actively serving on Bloom Standard’s medical advisory board since 2021 and has been instrumental in shaping the future of ultrasound technology. Her extensive background, coupled with her pioneering contributions to ultrasound standards and adoption outside of traditional imaging settings, will be invaluable. Her leadership is expected to bring new perspectives and strategies to the company's medical, translational R&D, and clinical development programs. Additionally, Dr. Abo was recently elected to the Executive Committee of the Section on Advanced Technology and Therapeutics (SOATT) of the American Academy of Pediatrics (AAP) and serves as a judge and mentor for MedTech Innovator.
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"We are thrilled to have someone of Dr. Abo’s caliber on the Bloom Standard executive team, and expect her deep experience, expertise, connections and enthusiasm to impact innovations and help catapult progress through clinical trials and beyond," said Annamarie Saarinen, CEO of Bloom Standard. “There’s no one better to help accelerate Bloom Standard’s efforts to make rapid triage imaging available to more clinicians and vulnerable patients at the earliest points of care than Dr. Abo.”
There are 1.3M children with heart conditions born each year. These patients still risk delayed, missed and misdiagnosis and are at greater risk of dangerous cardiopulmonary and respiratory illnesses, consistently the top cause of the more than 30 million pediatric ED visits each year in the US alone. This is a call to action to arm health staff on the front lines of care with a rapid and objective point of care assessment that can aid in ruling out the likelihood of cardiac, cardiopulmonary and respiratory conditions.
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About Bloom Standard
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The US Food and Drug Administration (FDA) granted Breakthrough Device Designation to Bloom Standard’s eva (echo view automation) RAPIDscan Ultrasound System as a novel breakthrough technology to provide rapid and essential information to aid in earlier detection and monitoring of heart and pulmonary conditions in neonatal and infant patients. As a rapid point-of-care triage tool, Bloom Standard’s RAPIDscan ultrasound system takes less than 3 minutes from patient data acquisition to results, enabling clinicians to get rapid, objective insights and clinical decision support regarding the likelihood of abnormal and potentially life-threatening cardiac and cardiopulmonary conditions. 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.
Greater than 90% of infants do not have immediate access to pediatric sonographers or the specialists required to acquire or interpret ultrasound images, which can result in delayed medical intervention, unnecessary or multiple patient transports, increased medical expenditures, longer lengths of hospitalization, additional procedures, and poorer health outcomes or even death. The RAPIDscan autonomous ultrasound imaging scanning pod and eva assistive clinical decision support software 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 patients in their local communities of care.
Bloom Standard has been instrumental in miniaturizing and automating ultrasound to support the development of new care pathways, starting earlier in the health care journey. Its proprietary EVA RAPIDscan self-driving ultrasound system is a user-agnostic, non-invasive ultrasound screening tool that consists of automated ultrasound hardware combined with AI-based clinical decision support software to acquire, process, and extract thousands of data points for rapid, actionable assessment on the front lines of care.
Development has been supported by FDA-funded Pediatric Device Consortia (PDC) program, including Children’s National Medical Center, the Alliance for Pediatric Device Innovation, UCSF-Stanford Pediatric Device Consortium, University of Minnesota Pediatric Device Innovation Consortium (now merged with the Southwest National Pediatric Device Innovation Consortium - SW PDIC). Other technical resources were provided through the Stanford Biodesign / Impact 1 program.
For more information about Bloom Standard and Dr. Alyssa Abo’s role as Chief Medical Officer, please contact:
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Jacob Colvin, COO
jake@bloomstandard.com
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
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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.