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Alife Health Achieves Milestone with CE Mark Certification for Embryo Predict™

In a significant advancement for fertility care, Alife Health has announced that its innovative embryo selection tool, Embryo Predict™, has received CE Mark certification under the European Medical Device Regulation (MDR). This achievement opens new avenues for the deployment of AI technology in reproductive health, marking a key milestone for the company in its mission to enhance patient outcomes through cutting-edge tools.

The Role of AI in Embryo Selection

Embryo Predict™ is a deep learning software platform specifically designed to assist embryologists in identifying the most viable embryos for transfer during in-vitro fertilization (IVF) procedures. Traditional embryo assessment relies heavily on subjective morphology observations, which can significantly vary between embryologists. Embryo Predict™ addresses this variability by digitizing and standardizing the embryo grading process. This tool is capable of capturing high-quality images of embryos, generating an AI score, and ranking each embryo based on its potential to lead to a successful clinical pregnancy. The incorporation of AI offers consistent, data-driven insights that elevate the standard of care in fertility treatments.

Improving Access to Fertility Care

Melissa Teran, CEO of Alife Health, expressed enthusiasm about the implications of achieving CE Mark approval: “This is a significant step in our mission to improve patient outcomes and expand access to fertility care. Now, with Embryo Predict available to clinics across Europe, we are closer to making a global impact in reproductive medicine.” The approval not only signals Alife's readiness to scale operations internationally but also highlights the growing intersection of technology and healthcare.

Collaboration and Innovation

Dr. Marcos Meseguer, Global Director of Embryology Research at IVIRMA and an instrumental collaborator in Alife’s journey, underscored the importance of integrating Embryo Predict™ into laboratory settings. He remarked on the tool's precision in scoring embryos and the straightforward integration with existing lab hardware. By combining human expertise with AI-derived insights, the medical community can significantly reduce subjectivity in embryo selection, enhancing overall decision-making processes. This kind of standardization is crucial in a field where the quality of embryo selection directly influences patient outcomes.

Future Plans and Commitment to Quality Care

With the CE Mark secured, Alife Health plans to rollout Embryo Predict™ across select IVF clinics throughout the European Union, building on their successes in the United States where their Clinical Decision Support (CDS) platform is already in use. Alife's commitment to improving clinical efficacy and patient care is evident in their effort to partner with leading IVF centers to disseminate AI technology that supports embryologists and ARTS (Assisted Reproductive Technology) practices.

About Alife Health

Alife Health is dedicated to personalizing and modernizing reproductive healthcare through advanced AI technologies. The company is recognized for its innovative approaches in the IVF process and has partnered with some of the leading clinics and experts in reproductive health. As a testament to its impactful contributions, Alife was acknowledged by Fast Company as one of the Most Innovative Companies of 2024, further establishing its position as a pioneer in this vital field.

For additional information on Embryo Predict™ and its potential benefits, clinics are encouraged to visit www.alifehealth.com or reach out via email for consultations.