Alife Health’s AI-powered selection tool, Embryo Predict, has received the CE Mark certification in compliance with the European Medical Device Regulation (MDR).
The tool is a software platform based on deep learning and aids embryologists in the task of choosing the most viable embryo for transfer during in vitro fertilisation (IVF) procedures.
It integrates with the current laboratory infrastructure, captures images of embryos, creates an AI score automatically, and ranks them based on their potential to result in a successful clinical pregnancy.
This process offers embryologists a consistent and data-driven approach to assist with embryo selection.
Alife Health noted that the conventional embryo evaluation can lead to significant variability in results.
By digitising and standardising embryo grading, the tool introduces a new level of quality control and utilises AI to identify patterns indicative of success from extensive datasets.
IVIRMA Embryology Research global director Dr Marcos Meseguer is partnering with the company on the European Council-sponsored embryo research.
Dr Meseguer said: "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.
"Alife brings a level of standardisation 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."
Following this clearance, the company is set to initiate the distribution of Embryo Predict to select IVF clinics throughout the EU.
This move builds upon the company's existing presence in the US, where it has already established its Clinical Decision Support (CDS) platform and formed alliances with clinic networks.
Alife Health CEO Melissa Teran said: "Achieving CE Mark approval is a significant step in our mission to improve patient outcomes and expand access to fertility care.
"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 centres across Europe to bring the benefits of AI to more patients."
