FertilAI has been awarded a CE mark (European conformity) under the EU Medical Device Regulation (EU MDR) for its predictive AI-based fertility platform, which is specifically designed to predict optimal treatment timing.

FertilAI’s Fertilane platform delivers two fertility-tailored algorithms. StimAI, which has received EU MDR Class IIa approval, 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. The second algorithm, OvuPredict, predicts natural cycle ovulation up to six days in advance. 

The predictions aim to optimise 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.

Fertilane, which has been trained on more than 100,000 cycles, can be integrated with leading electronic health record (EHR) systems, giving clinics direct access to AI tools within their existing systems. 

FertilAI CEO, Rohi Hourvitz, said: “Our goal is to accelerate and ease the patients’ fertility treatment journey to parenthood, no matter the path taken.” 

“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,” Mr Hourvitz said.