Alife Health, a technology company at the forefront of artificial intelligence in fertility care, has received CE Mark certification under the European Medical Device Regulation (MDR) for its AI-powered embryo selection tool, Embryo Predict™. The regulatory milestone enables the company to introduce its innovation to clinics and healthcare providers throughout Europe, marking a major step in its international expansion.

The CE Mark certification allows Alife Health to deploy its AI-powered embryo selection tool across European fertility centers, extending the company’s mission to bring data-driven precision to in vitro fertilization (IVF). Embryo Predict is built as a deep learning–based software platform that assists embryologists in selecting embryos with the highest potential for successful pregnancy. Integrated seamlessly into existing laboratory infrastructure, it captures embryo images, generates an automated AI score, and ranks embryos according to their likelihood of leading to a clinical pregnancy.

The company developed Embryo Predict to address one of IVF’s most subjective challenges, embryo grading. Historically, embryo assessment has relied on manual visual evaluation of morphology, which often varies between embryologists and laboratories. Embryo Predict aims to digitize and standardize this process, introducing a consistent method supported by AI. By analyzing extensive datasets, the AI-powered embryo selection tool can detect subtle success patterns beyond human perception, improving decision-making accuracy and adding a layer of quality control to fertility laboratories.

“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 clearance now secured, Alife Health plans to begin the phased rollout of Embryo Predict to select IVF clinics across the European Union. The company’s expansion builds upon its progress in the United States, where it has launched its Clinical Decision Support (CDS) platform and strengthened partnerships with leading fertility networks.

By combining AI and clinical expertise, Alife Health’s AI-powered embryo selection tool represents a new era in IVF technology , one aimed at enhancing outcomes, reducing variability, and improving the patient experience across global fertility care.