Fairtility has obtained CE Mark for its artificial intelligence (AI)-powered decision support tool, CHLOE EQ, under the requirements of the European Medical Devices Regulation (MDR).
The new tool has been developed to provide Embryo Viability Assessment, which supports blastulation, implantation and ploidy prediction as well as providing the ability to rank embryos in order of priority.
The company stated that CHLOE EQ also provides automatic annotations for morphokinetic and PN count, which support fertilisation assessment.
Fairtility clinical affairs vice-president Dr Cristina Hickman 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 tool provides information that helps embryologists and in vitro fertilization (IVF) professionals prioritise the most viable embryo for treatment, especially when there are multiple embryos that are deemed suitable.
It also improves the workflow of embryologists by automating manual steps, including embryo annotation, and writing daily observations in the electronic medical record (EMR) of each patient.
This allows embryologists to verify the automatic annotations, which are integrated directly into the EMR from the Time Lapse Incubator (TLI).
Fairtility CEO and co-founder Eran Eshed 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.”
The AI-powered decision support tool is commercially available for IVF fertility clinics across Europe.