B-Right AI Platform
Comprehensive AI platform for expert-level prenatal ultrasound support
Company profile
AI-powered prenatal ultrasound platform for expert-level fetal heart screening and exam completeness
Company profile
BrightHeart is a global leader in artificial intelligence solutions for prenatal ultrasound, specializing in fetal cardiac screening. The company's B-Right AI Platform empowers clinicians and sonographers to deliver expert-level care during routine prenatal ultrasound examinations. The platform consists of two main products: B-Right Screen, which provides AI-powered analysis of key structural markers to identify signs of severe congenital heart defects with 96% detection accuracy, and B-Right Views, which offers automatic protocol completion tracking and AI detection of standard fetal heart views. The system integrates seamlessly into existing workflows as a plug-and-play solution compatible with major ultrasound manufacturers. BrightHeart's mission is to deliver expert-level ultrasound care worldwide, regardless of resources, settings, or expertise. The company addresses a critical healthcare challenge: congenital heart defects are the most common birth defects worldwide, with 2 children born with CHD every minute, yet up to 70% go undetected during pregnancy and nearly 50% of fetal cardiac scans are incomplete. Founded by pediatric cardiologists and healthcare technology experts, BrightHeart has achieved FDA clearance and CE marking for its products, with clinical validation published in peer-reviewed journals including Obstetrics & Gynecology. The company is backed by leading healthcare investors and has deployed its technology in major healthcare systems including Mount Sinai Health System.
Company description BrightHeart official website
Mission. BrightHeart's mission is to empower perinatal healthcare professionals with innovative AI solutions that enhance the accuracy and efficiency of ultrasound assessments, ultimately improving patient outcomes. We aim to be the leading provider of AI-driven tools to transform perinatal care and ensure a brighter future for every child.
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01 · Operating footprint
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Hybrid deployment with recorded integration context.
Recorded integration context: Compatible with major ultrasound manufacturers, Existing reporting solutions, GE Healthcare Voluson Solution Store.
Company milestones
€11M Series A funding (January 2025), FDA clearance for both products, CE Mark approval and European launch (July 2026), GE Healthcare Voluson Solution Store collaboration (February 2026), Mount Sinai deployment as first NYC facility (December 2025), landmark study published in Obstetrics & Gynecology (September 2025)
Partnerships
02 · Flagship portfolio
Selected source-backed Company products and the available commercial context.
Comprehensive AI platform for expert-level prenatal ultrasound support
AI-powered screening for severe congenital heart defects in prenatal ultrasound
AI-driven protocol completion tracking for comprehensive prenatal ultrasound scans
03 · Research intelligence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Obstetrics and gynecology · Jan 1, 2026
Artificial Intelligence for the Detection of Fetal Ultrasound Findings Concerning for Major Congenital Heart Defects.Obstetrics and gynecology · Jan 1, 2026
Cancer immunotherapy.The Veterinary clinics of North America. Small animal practice · May 1, 2010
Cancer immunotherapy.Topics in companion animal medicine · Aug 1, 2009
Introduction.Topics in companion animal medicine · Aug 1, 2009
Anticancer vaccines.The Veterinary clinics of North America. Small animal practice · Nov 1, 2007
Clinical validation
No linked records are currently available.
Regulatory
K252294 · 510k · Dec 8, 2025
BrightHeart View ClassifierK251456 · 510k · Jun 5, 2025
BrightHeart View ClassifierK243684 · 510k · May 7, 2025
Fetal EchoScan (v1.1)K251071 · 510k · May 2, 2025
Fetal EchoScanK242342 · 510k · Nov 14, 2024
04 · Company-reported outcomes
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
B-Right Screen performance
B-Right Screen accuracy
B-Right Screen accuracy
B-Right Views workflow improvement
B-Right Views efficiency
B-Right Views clinician confidence
Clinical validation
Clinical validation
First center in New York City to implement AI-enhanced prenatal ultrasound screening for congenital heart defects at scale
More efficiency and improved sonographer satisfaction; physicians more comfortable reading exams
First in New York City to use FDA-cleared AI tool for enhanced fetal screenings for congenital heart defects
Near-perfect detection rates for congenital heart defects; earlier detection and better care for babies and families
Supporting sonographers with protocol completion tracking and image quality feedback during prenatal ultrasound scans
Install happened between seeing patients with no downtime; improved documentation completeness and image quality
05 · Leadership
Leadership profiles and professional links from the current Company record.
No active leadership profiles are currently listed.
06 · Company updates
Recent articles published on BrightHeart's official website.
07 · HAIC coverage
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Curated official destinations from the active Company record.
09 · Market pathway
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Market context
Companies that apply AI to analyze medical images for diagnostic purposes, workflow optimization, or clinical decision support. Covers general radiology (X-rays, CT scans, MRIs, ultrasounds) across multiple organ systems, as well as specialized imaging in ophthalmology and dermatology.
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