Overture Life Secures CE Mark for Fertility Automation in Europe
Overture Life’s Fertility Device Gains CE Mark for Europe
At a glance
- DaVitri receives CE Mark, enabling commercial distribution throughout Europe.
- First automated device approved in the EU and U.S. for freezing unfertilized eggs.
- Validated for post-thaw blastocyst development rates, underscoring effectiveness.
- Availability includes the United Kingdom, continental Europe, and Turkey.
Regulatory milestone
Overture Life has received CE Mark certification for its DaVitri automated fertility platform, paving the way for commercial distribution throughout Europe. The company’s Madrid and Palo Alto offices announced that DaVitri is the first device of its kind to earn regulatory approval for freezing unfertilized eggs in both the European Union and the United States. It is also the first egg-freezing system validated for post-thaw blastocyst development rates, supporting its effectiveness.
Why it matters
As global birth rates decline, access to assisted reproductive technology is increasingly critical. Automation and standardization can help clinics meet demand while improving consistency and safety in the lab.
About DaVitri
DaVitri is a tabletop solution designed to simplify the complex embryology process of vitrification—the rapid freezing of eggs—by automating this delicate procedure. By minimizing operator variability, DaVitri aims to reduce training time and deliver consistently reliable lab outcomes.
Leadership perspective
Hans Gangeskar, CEO of Overture Life, emphasized that CE Mark approval reflects European recognition of the need for reproductive autonomy and investments in fertility infrastructure. With this regulatory green light, Overture Life can offer DaVitri across the United Kingdom, continental Europe, and Turkey.
Market context
Overture Life has raised about $70 million in the United States, where tight clinic capacity often drives the cost of a single IVF cycle to $15,000 or higher. Automation platforms like DaVitri are positioned to help clinics expand capacity and improve predictability of outcomes.
Broader portfolio
Beyond DaVitri, Overture Life’s portfolio includes ICSI.A, a robotic fertilization device credited with the first births from fully automated fertilization in 2023, and the m|z platform, which uses AI and metabolomics for non-invasive embryo health assessment in Texas.
Mission and footprint
Integrating engineering, reproductive medicine, and rigorous validation, Overture Life is modernizing IVF procedures to lower costs and enhance access. With research and development in Spain and operations in the U.S., the company focuses on reliable, scalable fertility solutions for women and families worldwide.
For clinics and partners
Clinics interested in DaVitri can find more information or reach out to the company via their website or email.
