Future Fertility's AI-powered oocyte-assessment tools receive CE Mark


Future Fertility's AI-powered oocyte-assessment tools receive CE Mark under the new European Union Medical Device Regulation (MDR)

Future Fertility, a health technology company developing non-invasive AI-based fertility solutions, announces the achievement of CE Mark under the new European Union Medical Device Regulation (MDR). This major milestone comes as Future Fertility solidifies its presence in Europe, working with leading-edge IVF clinics to optimize fertility care through first-of-their-kind oocyte assessment tools Violet and Magenta.

Future Fertility is the first company to use 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.

"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," says Christy Prada, Future Fertility CEO. "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. These regulatory achievements represent a significant step in Future Fertility's vision to unlock the future of personalized fertility care around the world.

"We're thrilled that this exciting technology can now be offered here in Europe," says Dr. Štěpán Machač, Chief Medical Officer of FutureLife, one of the largest fertility networks in Europe. "Our clinics are known to lead the industry with innovative offerings and we are excited to be collaborating with Future Fertility to pilot in our clinics. These tools represent an exciting new frontier for both professionals and their patients alike."