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NewsNewsAlife Health secured CE Mark approval for its AI-powered embryo selection tool, Embryo Predict, under EU MDR, expanding its fertility technology presence across Europe.
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.
India's Central Drugs Standard Control Organisation has overhauled CDSCO IVF reagent sale norms, directing that all ART media, culture solutions, and reagents be supplied exclusively to clinics registered under the ART (Regulation) Act and Surrogacy (Regulation) Act. The move targets a growing unlicensed supply chain feeding an estimated 40–50% of India's 2,000-plus IVF centres.
Abu Dhabi University and FertiClinic Group have joined forces to establish the FertiClinic Reproductive Research Lab, an advanced reproductive research lab in Abu Dhabi housing IVF, andrology, and cryopreservation facilities. The partnership supports UAE national priorities, bridges academic and clinical expertise, and advances fertility innovation across the region.
NHS Kent and Medway has overhauled its fertility funding policy in a move that sees NHS cuts IVF access for thousands of patients. Effective 1 April 2026, the eligible age ceiling drops from 40 to 38, funded cycles fall from two to one, and embryo transfers are capped at two.
ASEAN's First Telemedicine IVF by Inspire IVF introduces a new era of remote fertility care. Combining AI technology with expert consultation, the platform enables global access, real-time monitoring, and personalised treatment planning, positioning Thailand as a leading hub for fertility services and advancing digital transformation in reproductive healthcare.
CSG.BIO has gone ahead with the acquisition of Hanabusa IVF, Asian Egg Bank, thereby making it a world leader in reproductive medicine and cutting-edge clinics with enhanced patient reach and advanced laboratory capabilities.
Wisconsin lawmakers from both parties are proposing bills to reduce IVF treatment costs. Republicans suggest a $5,000 tax credit for expenses, while Democrats want mandatory insurance coverage. With IVF cycles costing $20,000-$30,000 and 170,000 residents facing infertility, both parties seek affordable solutions through different approaches.
The AI-specialized Infertility Center, which is the largest in Asia, is open in Magok, Seoul and has begun its full-scale medical services from November 17 thereby marking the new era when it comes to fertility in the region.
