Alife Health Receives FDA Clearance for AI Fertility Tool Embryo Predict

Alife Health has received clearance from the U.S. Food and Drug Administration (FDA) for its artificial intelligence system Embryo Predict, announced in a press release. The tool assists fertility specialists in assessing and selecting embryos for transfer during in vitro fertilization.

Embryo Predict uses AI to analyze images of embryos and generate a score based on patterns learned from thousands of embryo outcomes across global clinics and patient profiles. It integrates with existing microscopes and imaging systems in fertility labs without requiring new hardware.

The FDA clearance followed a prospective, randomized clinical trial conducted at seven U.S. centers, involving 440 patients. The trial compared embryo selection assisted by AI with standard evaluation methods.

The system is designed to analyze images of Day 5, 6, and 7 blastocyst-stage embryos considered suitable for transfer. It provides additional information to support embryologists in selecting embryos for transfer or freezing. Embryo Predict also holds CE Mark certification and is commercially available in the United States, Europe, and the United Kingdom.