BrightHeart, a global leader in artificial intelligence (AI) solutions for obstetrics and pediatric cardiology, announced today the 510(k) clearance for updates to the BrightHeart platform, adds the capability for clinicians to access the BrightHeart analysis in real-time through a cart-side tablet.
BrightHeart's innovative AI technology addresses a critical unmet clinical need, targeting the significant challenge of screening for congenital heart defects (CHDs), the most common type of birth defect. Currently, up to 70% of CHDs cases go undetected during routine prenatal ultrasounds due to the complexity of these exams. BrightHeart offers a first of its kind digital screening tool, which applies AI to flag findings on structural markers that may be suggestive of CHDs. This first offering supports the company's broader vision to deliver expert level ultrasound care, regardless of resources, setting, or expertise.
"Our product expansion builds upon the success of our initial pilot experience, bringing real-time feedback directly to the clinicians to streamline the workflow and enhance accuracy," said Cécile Dupont, BrightHeart CEO and Partner at Sofinnova Partners. "Our team rapidly executed from concept to pilot implementation of the BrightHeart tablet in clinics, and we were thrilled to achieve clearance through our first Special 510(k) submission within just a few months."
"The clinician reception to the BrightHeart tablet has been very positive during our pilot experience," said Dr. Jennifer Lam-Rachlin, Maternal Fetal Medicine Assistant Professor at Icahn School of Medicine at Mount Sinai Hospital/Mount Sinai West Hospital, Director of Fetal Echocardiography at Carnegie Imaging for Women. "With real-time alerts on structural markers, BrightHeart supports efficiency in the fetal heart evaluation by bolstering the analysis and documentation for both normal and abnormal scans ultimately boosting confidence and consistency in the exam room."
"Heart defects are so hard to detect, and so devastating if missed," said Dr. Sara Garmel, Perinatologist and Founding Partner at Michigan Perinatal Associates, PC. "By surfacing the alerts directly during the scan, BrightHeart helps bring greater structure and efficiency to fetal heart exams to support earlier and more accurate detection."
With multiple clearances achieved in record time, BrightHeart is preparing for the limited market release to deploy BrightHeart in an exclusive set of clinics. BrightHeart invites clinicians, researchers, and industry leaders to join us and collaborate in advancing maternal-fetal health. Together, we can reshape the future of prenatal care.
About BrightHeart
BrightHeart SAS is a Paris-based, privately held, medical device company and part of Sofinnova MD Start, Sofinnova Partners' medical device accelerator. The company's software uses cutting-edge artificial intelligence to analyze fetal heart ultrasound exams and support clinicians and sonographers with tools to improve fetal heart evaluations.
BrightHeart builds on more than a decade of foundational excellence and innovation in fetal cardiology training established by co-founders Dr. Marilyne Levy and Dr. Bertrand Stos, two leading fetal cardiologists based in Paris, France.
About Sofinnova Partners
Sofinnova Partners is a leading European venture capital firm in life sciences, specializing in healthcare and sustainability. Based in Paris, London and Milan, the firm brings together a team of professionals from all over the world with strong scientific, medical, and business expertise. Sofinnova Partners is a hands-on company builder across the entire value chain of life sciences investments, from seed to later-stage. The firm actively partners with ambitious entrepreneurs as a lead or cornerstone investor to develop transformative innovations that have the potential to positively impact our collective future.
Founded in 1972, Sofinnova Partners is a deeply established venture capital firm in Europe, with 50 years of experience backing over 500 companies and creating market leaders around the globe. Today, Sofinnova Partners has over €4 billion under management. For more information, please visit: www.sofinnovapartners.com.
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Contacts:
For further information:
Cécile Dupont
Chief Executive Officer, BrightHeart
press@brightheart.fr