Menlo Park, Calif., devicemaker Auxogyn said Tuesday that its first product, the Eeva System, was cleared for marketing via the FDA’s de novo classification process — a relatively new pathway for novel low-to-moderate-risk devices that are first-of-a-kind. 

The system allows in vitro fertilization clinicians to offer their patients the exclusive Eeva Test, the first prognostic, noninvasive diagnostic to deliver quantitative information about embryo development, Auxtogyn said. The test uses proprietary software that automatically analyzes embryo development alongside scientifically derived cell-division timing parameters, taken through continual video imaging.

This helps clinicians identify embryos with the highest development potential and select those for implantation, the company said.

The Eeva System is CE-marked and available in the EU and Canada. In April 2014, Auxogyn signed a licensing agreement giving Merck KGaA exclusive rights to commercialize the Eeva Test in Europe and Canada.

Auxogyn is ramping up for a U.S. rollout later this year, said company spokeswoman Diana Soltesz. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.