Fairtility’s AI decision-support tool granted CE mark under new MDR

Fairtility’s AI decision-support tool CHLOE EQ™ has earned the CE Mark under the European Medical Devices Regulation (MDR) regulatory requirements and is now commercially available to fertility clinics across Europe.

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 provides automatic annotations for morphokinetic and PN count which support fertilisation assessment.

According to Dr. Cristina Hickman, Fairtility VP of Clinical Affairs and leading embryology expert, embryo evaluation and selection has traditionally 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™ was designed to offer is accuracy and consistency in assessment,” she adds. “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.

The tool 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, says that: “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.”

The European MDR came into effect in May 2021 and serves as the new European legal framework for medical devices. MDR has more stringent requirements for demonstrated compliance, vis a vis the obsolete Medical Device Directive (MDD), the previous industry standard.

Fairtility is showcasing CHLOE EQ™ at the 38th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE), taking place in Milan Italy from July 3-6, 2022 with five oral presentations and seven posters supporting the clinical impact of the product.

In vitro fertilisation (IVF) is the most effective form of assisted reproductive technology. Due to the complexity of the procedure, however, prediction of embryonic implantation prior to IVF is key in decision-making.

The Israeli software company Fairtility aims to maximise IVF outcomes by using AI and computer vision algorithms to provide early, data-driven embryo quality.

For more info, visit fairtility.com.