AI embryo selection tool wins European approval

Alife Health’s AI-powered embryo selection software has received CE Mark certification under the European Medical Device Regulation (MDR), allowing it to be used in fertility clinics across Europe.

The San Francisco-based company said its Embryo Predict system, which supports embryologists in selecting the best embryo for transfer, can now be marketed across EU countries following MDR approval.

The software uses deep learning – a type of artificial intelligence that mimics how the brain processes information – to help embryologists assess embryos during IVF.

It captures embryo images, generates an AI score and ranks them according to their likelihood of resulting in a clinical pregnancy.

Traditional embryo assessment relies on manual observation of embryo morphology – the study of its shape and structure – which can vary between embryologists.

The AI tool aims to standardise this process by analysing large datasets and detecting subtle patterns beyond what the human eye can identify.

Melissa Teran, CEO of Alife Health, 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.”

With MDR clearance secured, Alife plans to roll out Embryo Predict to selected IVF clinics across the EU, building on its existing momentum in the US, where it operates a clinical decision support platform and partners with leading fertility networks.

Alife Health develops AI-driven tools to modernise and personalise IVF.

The company has not disclosed pricing for the European market or timelines for individual country launches.

Dr Marcos Meseguer is global director of embryology research at IVIRMA, who is collaborating with Alife on innovative embryo research sponsored by the European Council.

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.”