Alife Health, a San Francisco-based digital health company, has received FDA clearance for Embryo Predict, an AI tool that analyzes embryo images and generates scores to help fertility specialists evaluate and select embryos for transfer during IVF.
Embryo selection is one of the most consequential decisions in the IVF process – and one of the most subjective. Published research found a 34.6% disagreement rate among fertility specialists selecting the top embryo for transfer, rising to 44% when patients had three or more embryos to choose from. Embryo Predict draws on patterns learned from thousands of embryos and their outcomes across clinics, geographies, and patient profiles worldwide, integrating with existing microscopes and imaging systems with no new hardware required.
The clearance was supported by a prospective, randomized, multi-center clinical trial enrolling 440 patients across seven U.S. clinics, evaluating AI-assisted embryo selection compared to standard evaluation alone.
“Six years ago, we set out to put IVF’s wealth of clinical data to work in a way the field had never seen before. Today, that work is validated,” said CEO and co-founder Melissa Teran. “For the first time, the collective insight from thousands of embryos and outcomes around the world is available to every embryologist, at every transfer decision.”
Embryo Predict also holds CE Mark under EU Medical Device Regulation, making it available across Europe and the UK. The product is now commercially available in both markets.
