Alife Health Receives CE Mark Under European Medical Device Regulation for Embryo Predict™, Its AI-Powered Embryo Selection Tool
SAN FRANCISCO, Oct. 23, 2025 /PRNewswire/ -- Alife Health, a health tech company advancing the future of fertility care with artificial intelligence, today announced that Embryo Predict™, its AI-powered embryo selection tool, has received CE Mark certification under the European Medical Device Regulation (MDR). This approval marks a new era for Alife's expansion into international markets and brings its cutting-edge technology to healthcare providers throughout Europe.
Embryo Predict is a deep learning–based software platform designed to support embryologists in selecting the best embryo for transfer. By integrating directly with existing lab infrastructure, the system captures embryo images, automatically generates an AI score, and ranks embryos according to their likelihood of resulting in a clinical pregnancy. This provides embryologists with consistent, data-driven insights to support embryo selection and brings a new level of standardization to the lab.
Embryo Predict was developed to address one of the most important, yet highly subjective, aspects of IVF: embryo grading. Traditional embryo assessment relies on manual observation of morphology, which can vary significantly between embryologists. Embryo Predict digitizes and standardizes this process, adding an additional layer of quality control and harnessing the power of AI to detect patterns of success from a vast dataset, providing data-driven insights that go beyond the limits of the human eye or the judgment of any single individual.
"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 innovative embryo research which is 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."
With MDR regulatory clearance secured, Alife will begin rolling out Embryo Predict to selected IVF clinics across the EU, expanding on the company's momentum in the US with their Clinical Decision Support (CDS) platform and their partnerships with leading networks.
Clinics interested in Embryo Predict can visit www.alifehealth.com or contact clinics@alifehealth.com.
About Alife Health
Alife Health is modernizing and personalizing the IVF process with cutting-edge AI technology designed to improve clinical outcomes and patient care. With partnerships across the top clinics and renowned physicians in the field, Alife is transforming reproductive healthcare. Recognized by Fast Company as one of the Most Innovative Companies of 2024, Alife is pioneering AI solutions that support embryologists, clinics, and patients on the IVF journey: www.alifehealth.com.
Media Contact
Jamie Gray, press@alifehealth.com
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