Future Fertility, a healthtech company developing non-invasive AI-based fertility solutions has received CE Mark approval under the new European Union Medical Device Regulation (MDR). The company uses artificial intelligence to analyze 2D images of oocytes and generate personalized, validated insights for egg-freezing and IVF patients. Its tools have been proven through scientific evidence to detect features that are invisible to the human eye and more accurately predict the likelihood of fertilization and embryo (blastocyst) development. By uniquely offering insights about oocyte viability rather than embryos, this advancement empowers clinicians, embryologists, and patients to make more informed treatment decisions.
Christy Prada, Future Fertility CEO, explains: “The importance of egg quality for successful treatment outcomes is well established, but there were no tools that could accurately and reliably provide that insight. Using machine-learning, Violet and Magenta have proven to close that gap, and with the CE Mark, we can now bring this game-changing technology to more clinics internationally.”
Along with the newly attained CE Mark, Future Fertility’s tools already have Health Canada approval, and the company is pursuing FDA approval over the coming months. The company announced an undisclosed amount in Series A funding in January 2022.