Tel Aviv-based FertilAI has received CE marking under the EU Medical Device Regulation for two AI-driven clinical decision support algorithms designed to help fertility clinicians optimize treatment timing during active cycles.
The platform, called Fertilane, delivers two algorithms trained on more than 100,000 cycles, according to the company:
StimAI (EU MDR Class IIa) predicts the expected number of mature oocytes retrieved based on multiple trigger timings, supporting physicians in making treatment decisions for IVF outcomes while helping clinics balance daily laboratory workload.
OvuPredict (EU MDR Class I) predicts natural cycle ovulation up to six days in advance. Published research in Nature Scientific Reports suggests such predictions may help optimize the timing of intrauterine insemination (IUI) and frozen embryo transfers (FET), improving pregnancy chances while reducing patient monitoring requirements.
Fertilane is a SaaS platform integrated with leading EMR systems, giving clinics access to AI tools within their existing workflows.
“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,” said CEO Rohi Hourvitz. “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.”
The algorithms have been validated through multiple peer-reviewed studies published in Fertility and Sterility, Reproductive BioMedicine Online, and Nature Scientific Reports, with randomized controlled trials ongoing. FertilAI was founded by clinical specialists and technology experts.
