FertilAI announced on April 15, 2026, that it has received CE marking under the EU Medical Device Regulation (EU MDR) for its clinical decision-support tools. The clearance applies to StimAI and OvuPredict, which are integrated into the company’s Fertilane platform to assist physicians with clinical timing during active treatment cycles. This development introduces a regulated application of Predictive AI in Fertility specifically designed to predict mature oocyte yields and natural cycle ovulation. StimAI, an EU MDR Class IIa device, forecasts the number of mature oocytes retrieved across different trigger timings to support IVF outcomes and laboratory workload management. OvuPredict, classified as EU MDR Class I, predicts ovulation up to six days in advance to assist in timing intrauterine insemination (IUI) and frozen embryo transfers (FET).

The Fertilane system is a SaaS solution that integrates with existing electronic medical record (EMR) systems. Its algorithms were developed using data from more than 100,000 cycles to support individualized care and operational scheduling. By utilizing Predictive AI in Fertility, the platform aims to reduce patient monitoring requirements and balance daily clinic workloads without affecting clinical outcomes. The technology is intended to provide data-driven insights during active treatment cycles, allowing for more predictable daily scheduling in both medical and laboratory environments.

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 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.
  
  

FertilAI CEO Rohi Hourvitz stated that the EU MDR validation confirms the technology’s role in streamlining clinic operations and increasing service access without raising overhead. The advancement of Predictive AI in Fertility is positioned to address physician shortages and rising infertility rates. Hourvitz commented, "Our goal is to accelerate and ease the patients' fertility treatment journey to parenthood, no matter the path taken". He added, "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. 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".