- AI
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- Mammography
FDA Clears AI Software for Fetal Heart Ultrasound Assessment
Reportedly developed on over 90,000 ultrasound exams, the BrightHeart AI software identifies suspicious findings suggestive of congenital heart defects through AI-powered evaluation of fetal heart morphology.
The Food and Drug Administration (FDA) has granted 510(k) clearance for BrightHeart’s artificial intelligence (AI)-enabled software, which may bolster ultrasound detection of congenital heart defects (CHDs) that have been estimated to occur in one of every 100 newborns.
Employing AI algorithms that were developed on over 90,000 ultrasound exams, BrightHeart’s AI software provides automated video stream analysis and detailed assessment of fetal heart morphology, which detects or rules out findings suggestive of CHDs, according to BrightHeart.
Offering detailed assessment of fetal heart morphology and automated video stream analysis, the newly FDA-cleared AI software from BrightHeart may enhance ultrasound detection of congenital heart defects. (Image courtesy of BrighHeart.)
The company says the software also offers AI assessment as to the completeness of fetal heart ultrasound exams and facilitates smooth integration into existing ultrasound workflows.
“Fetal heart assessments are among the most technically demanding aspects of prenatal ultrasound,” said Cécile Dupont, the CEO of BrightHeart. “Our AI-powered solution not only assists clinicians in detecting signs of potential abnormalities earlier but also enhances their confidence in confirming normal findings, which is equally critical for the peace of mind of expectant families.”
Mammography Study Suggests DBT-Based AI May Help Reduce Disparities with Breast Cancer Screening
December 13th 2024New research suggests that AI-powered assessment of digital breast tomosynthesis (DBT) for short-term breast cancer risk may help address racial disparities with detection and shortcomings of traditional mammography in women with dense breasts.
The Reading Room: Artificial Intelligence: What RSNA 2020 Offered, and What 2021 Could Bring
December 5th 2020Nina Kottler, M.D., chief medical officer of AI at Radiology Partners, discusses, during RSNA 2020, what new developments the annual meeting provided about these technologies, sessions to access, and what to expect in the coming year.
Mammography News: FDA Grants Expanded 510(k) Clearance for AI-Powered SmartMammo Dx DBT Software
November 29th 2024Originally cleared by the FDA in 2021, the SmartMammo Dx software for digital breast tomosynthesis (DBT) can now be utilized with the Senographe Pristina mammography systems from GE HealthCare.
