IVF decision support tool CE marked under MDR

Fairtility, the AI innovator powering in vitro fertilisation (IVF) for improved outcomes, has seen its AI decision support tool CHLOE EQ earn the CE mark under the European Medical Devices Regulation (MDR) regulatory requirements. 

CHLOE EQ is an AI decision support tool that was 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 fertilisation assessment.

Dr. Cristina Hickman, Fairtility VP of clinical affairs and embryology expert said: “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 prioritising 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.

Eran Eshed, CEO and co-founder of Fairtility, said: “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. 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 US market entry.”