Alife Health has received CE Mark certification under the European Medical Device Regulation for Embryo Predict, its AI-powered embryo selection tool.
Embryo Predict is a deep learning software platform that supports embryologists in selecting embryos for transfer. The system integrates with existing lab infrastructure to capture embryo images, generate an AI score, and rank embryos according to their likelihood of resulting in clinical pregnancy.
Traditional embryo assessment relies on manual observation of morphology, which can vary between embryologists. Embryo Predict digitizes and standardizes this process, using AI to detect patterns from a dataset to provide data-driven insights.
“Achieving CE Mark approval is a significant step in our mission to improve patient outcomes and expand access to fertility care,” said Melissa Teran, CEO of Alife Health. “With Embryo Predict now available to clinics across Europe, we have moved one step closer to our goal of achieving global impact in reproductive medicine. We look forward to partnering with leading IVF centers across Europe to bring the benefits of AI to more patients.”
“I was impressed not only by Embryo Predict’s precision in scoring embryos, but also by the simplicity of its integration with existing laboratory hardware,” said Dr. Marcos Meseguer, Global Director of Embryology Research at IVIRMA, who is collaborating with Alife on embryo research sponsored by the European Council. “Alife brings a level of standardization and objectivity to embryo selection that our field needs. By combining human expertise with AI-driven insight we will reduce subjectivity and improve decision-making.”
Alife will begin rolling out Embryo Predict to selected IVF clinics across the European Union. The company operates a Clinical Decision Support platform in the United States and has partnerships with leading networks.
