Overture Life Receives CE Mark Approval to Commercialize Fertility Automation in Europe

DaVitri becomes the first automated device cleared in the EU or U.S. for the vitrification of unfertilized eggs and the first freezing system approved with a blastocyst-rate performance claim

MADRID & PALO ALTO, Calif.--(BUSINESS WIRE)--Overture Life, the global leader in automated IVF and the first company to achieve live births from both robotic fertilization and robotic egg freezing, announced that the company has secured CE Mark certification for its DaVitri platform to expand access to automated in vitro fertilization (IVF) technology. DaVitri is now the first automation device with regulatory clearance for freezing unfertilized eggs in either the EU or the U.S., and the first freezing system granted approval with a validated claim for post-thaw blastocyst development rates. The milestones provide the company with the support needed to commercialize in Europe and the regulatory clearance to bring DaVitri to continental Europe as well as the UK and Turkey which also accept CE mark.

Access to assisted reproduction is a critical and growing issue amid declining birth rates globally. Overture Life’s DaVitri is a tabletop device that enables egg freezing beyond throughput-constrained fertility clinics. By automating one of the most technically demanding embryology steps, vitrification of unfertilized oocytes, DaVitri reduces operator variability, simplifies training, and delivers consistency backed by lab-verified embryo formation outcomes.

“This is a signal that Europe understands the personal and demographic urgency of reproductive freedom," said Overture Life CEO Hans Gangeskar. “The EU has shown its willingness to make long-term public investments in fertility infrastructure and support new technologies, and we hope to see other jurisdictions follow the same path.”

Overture Life has raised about $70 million in the U.S., where supply bottlenecks have driven the cost of a single IVF cycle to $15,000 or more.

The rest of Overture Life’s innovative portfolio continues to mature as well. Use of its ICSI.A robot resulted in the first two live births resulting from an automated fertilization device in 2023, and its AI+metabolomics-based m|z platform for non-invasive healthy embryo selection is now accessible through a CLIA (Clinical Laboratory Improvement Amendments)-certified laboratory in Texas.

Clinics interested in DaVitri can contact [e-mail] and visit https://www.overture.life/davitri.

About Overture Life

Overture Life integrates engineering, reproductive medicine, and regulatory-grade validation to modernize embryology lab procedures, particularly egg freezing and embryo handling, in ways that lower repeated cycles, increase throughput, and reduce the overall cost of IVF. With R&D in Spain and active U.S. operations, including a CLIA-licensed laboratory for non-invasive embryo selection, Overture unites robotics, analytics, and clinical rigor to deliver tools that clinics and patients can trust. The company’s DaVitri platform aims to boost reliability and consistency in IVF, giving women and families worldwide more control over their fertility timelines. Overture’s backers include Overwater Ventures, GV, Khosla Ventures, Octopus Ventures and others committed to advancing the future of fertility.