Fairtility has achieved FDA 510(k) clearance for CHLOE Blast, an AI-driven embryo assessment tool within its CHLOE platform. This FDA-cleared machine learning software provides objective evaluations of embryo images, surpassing traditional manual methods. With widespread use across Europe, Canada, and Asia Pacific, CHLOE Blast aims to tackle the rising infertility rates in the U.S., where infertility rates among married women climbed from 6.7% (2011-2015) to 8.7% (2015-2019), impacting nearly 10% of women of reproductive age.
CEO Eran Eshed emphasizes the shift from subjective assessments to data-driven processes, enhancing workflow efficiency and communication between doctors and patients. Dr. Said Daneshmand highlights the technology’s role in fertility care improvement, offering real-time insights without complicating operations. Overall, this FDA clearance represents a significant advancement in AI research, transforming IVF decision-making and offering a more transparent, empowering experience for both clinicians and patients.
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