Fairtility has received FDA 510(k) clearance for CHLOE Blast, an AI-powered embryo assessment tool within its CHLOE platform. The company describes it as the FDA-cleared machine learning clinical decision support software for embryo assessment.
CHLOE Blast analyzes time-lapse embryo images to provide more objective and consistent evaluations compared to manual assessment methods. The technology has been commercially used with tens of thousands of patients outside the United States across Europe, Canada, and Asia Pacific.
The clearance addresses growing infertility rates in the United States, where the CDC reports infertility among married women increased from 6.7% in 2011-2015 to 8.7% in 2015-2019. Nearly 1 in 10 married women of reproductive age now face infertility challenges.
“With this FDA clearance, CHLOE is setting a regulatory precedent in this space,” said Eran Eshed, CEO and Co-Founder of Fairtility. “We are shifting the industry from subjective and manual assessment to an objective, data-driven and more automated one.”
The CHLOE platform supports embryologists with consistent embryo and oocyte assessments while providing doctors with tools to communicate more clearly with patients. The system aims to enhance workflow efficiency and bring transparency to the IVF patient journey.
“This technology represents a meaningful advancement in the practice of fertility care,” said Dr. Said Daneshmand, Reproductive Endocrinologist with San Diego Fertility Center. “Through continuous monitoring of embryo development with time-lapse imaging, coupled with explainable artificial intelligence, it provides physicians with real-time, interpretable insights without adding unnecessary complexity to the workflow.”
The AI tool provides continuous monitoring of embryo development and integrates with embryology laboratory workflows. The system expands the number of measurable datapoints available to physicians for treatment decisions.
“This FDA clearance marks a turning point where years of AI research translate into real progress for patients,” said Jason Barritt, PhD, a U.S.-based assisted reproductive lab director. “With CHLOE, IVF decision-making becomes more consistent, transparent, and empowering for both clinicians and patients.”
