CE Mark Granted for IVF Decision Support Tool

Fairtility’s AI decision support tool CHLOE EQ has earned CE Marking under the European Medical Devices Regulation (MDR) regulatory requirements.

Now commercially available to IVF fertility clinics throughout Europe, CHLOE EQ is an AI decision support tool developed to provide embryo viability assessment—which supports the prediction of blastulation, the prediction of implantation and ploidy and, ranks embryos in order of priority. It also provides automatic annotations for morphokinetic and PN count which support fertilization assessment.
 
According to Dr. Cristina Hickman, Fairtility VP of Clinical Affairs and leading embryology expert, “Traditionally, embryo evaluation and selection has been a manual process, limiting patient access to treatment while also opening the door for human error. One of the key advantages that CHLOE EQ™, the transparent AI-driven embryo quality assessment tool, was designed to offer is accuracy and consistency in assessment. CHLOE’s proprietary AI-based algorithms become more accurate the more data it gathers, leading to uniform and accurate embryo assessment.”
 
The information provided by CHLOE EQ can then assist embryologists and IVF professionals in the decision of prioritizing the most viable embryo for treatment, especially when there are multiple embryos deemed suitable.
 
CHLOE EQ is designed to add efficiency to embryologists’ workflow, automating manual steps, including annotation of each embryo and written daily observations into each patient’s electronic medical record (EMR). Embryologists verify the system’s automatic annotations that are then immediately integrated from the Time Lapse Incubator (TLI) directly into the EMR.
 
“Having gained regulatory acknowledgement in Europe, under the more stringent directive that the CE MDR provides, we are now commercially launching CHLOE EQ in clinics across the EU while continuing to uphold the highest standard of this classification,” said Eran Eshed, CEO and co-founder of Fairtility. “With the EU IVF market size estimated to reach over $2 billion by 2027, we see tremendous opportunities to demonstrate the clinical efficacy and impact of CHLOE EQ™ ahead of U.S. market entry.”
 
Fairtility is powering in vitro fertilization (IVF) through transparent AI to improve outcomes. Equipping clinicians and their patients with visibility into IVF treatment, CHLOE (Cultivating Human Life through Optimal Embryos) is the first and only transparent AI-based decision support tool that provides clinicians with complete visibility into the clinical and laboratory parameters that make up data output to help improve IVF outcomes. Beginning with CHLOE EQ, a proprietary embryo grading platform, Fairtility is on a path to expand CHLOE’s application to span the full IVF journey—from infertility cause assessment through transfer optimization.