EU Medical Device Regulation (MDR) clearance for StimAI and OvuPredict empowers fertility clinics to predict optimal treatment timing, enhance clinical precision, and achieve intelligent workload balancing.
TEL AVIV, Israel, April 15, 2026 /PRNewswire/ -- FertilAI has received CE marking under the EU Medical Device Regulation (EU MDR) for its AI-driven clinical decision support tools. To the company's knowledge, their solution is the world's first CE-marked predictive AI-based fertility platform specifically designed to support the physician's clinical timing decisions during active treatment cycles. By predicting ovulation and expected mature oocyte yields across different trigger timings, FertilAI empowers physicians to make optimal clinical decisions using data-driven insights during active fertility treatment cycles.
FertilAI's Fertilane platform enhances clinical precision and operations. It's a seamless SaaS solution integrated with leading electronic medical record (EMR) systems, giving clinics direct access to AI tools within their existing systems. Trained on more than 100,000 cycles, the newly approved algorithms support individualized patient care while helping clinics intelligently balance daily medical and laboratory workloads without compromising clinical outcomes.
Fertilane delivers two fertility-tailored algorithms:
- StimAI (EU MDR Class IIa): Predicts the expected number of mature oocytes retrieved based on multiple trigger timings. This supports physicians in making optimal treatment decisions for IVF outcomes while allowing the clinic to better balance the daily IVF laboratory workload.
- OvuPredict (EU MDR Class I): Supports clinicians by predicting natural cycle ovulation up to six days in advance. According to published literature (Nature Scientific Reports), such predictions may help optimize the timing of intrauterine insemination (IUI) and frozen embryo transfers (FET), significantly improving pregnancy chances. Operationally, it may assist in reducing patient monitoring requirements while facilitating more predictable daily scheduling.
"Our goal is to accelerate and ease the patients' fertility treatment journey to parenthood, no matter the path taken," said FertilAI CEO Rohi Hourvitz. "Achieving the CE mark under the EU MDR validates our technologies' ability to support more effective clinical decision making and simultaneously streamline clinic operations, all while increasing patient access to services without growing clinic overhead.
"With the global rise in infertility and a worldwide shortage of physicians driving higher costs and longer wait times, expanding access to care is absolutely vital," Hourvitz continued. "Having a system that enables clinic scalability while actively improving clinical benefits and the patient experience is a pivotal step forward in addressing this growing challenge."
About FertilAI
FertilAI is a healthcare company developing technologies that improve fertility treatments' success rates and assist clinicians in their decision making, while simultaneously elevating the patient experience and supporting clinics' ability to scale. FertilAI was founded by clinical specialists and technology experts who recognize the crucial need to apply the latest developments in artificial intelligence to the fertility treatment process. Its technologies have been validated with multiple published studies, which have appeared in peer-reviewed journals including Fertility and Sterility, Reproductive BioMedicine Online (RBMO), and Nature Scientific Reports, Randomized controlled trials are ongoing, as well. For more information, visit www.fertilai.com.
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