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Mount Sinai Rolls Out FDA-Cleared BrightHeart AI for Fetal Ultrasounds Across Manhattan

Peer-reviewed results show AI assistance pushed detection of suspicious major heart defects above 97%, with faster reads and higher clinician confidence.

Overview

  • Carnegie Imaging for Women, a Mount Sinai–affiliated center with three Manhattan locations, is the first in New York City to deploy the FDA-approved BrightHeart software at scale.
  • An Obstetrics & Gynecology study led by Mount Sinai West reported detection of ultrasound findings suspicious for major congenital heart defects exceeding 97%, with an 18% reduction in reading time and a 19% gain in confidence.
  • The randomized reader study analyzed 200 deidentified second-trimester exams from 11 medical centers across two countries, interpreted by 14 specialists with and without AI assistance.
  • Study authors say the tool could help standardize prenatal cardiac screening by offering near–expert-level review in settings that lack fetal heart specialists.
  • The research was funded by BrightHeart, and the team urges further evaluation of workflow integration, generalizability, and downstream clinical impacts.