Alife Health Receives FDA Clearance for AI-Powered Embryo Assessment
Alife Health Receives FDA Clearance for AI-Powered Embryo Assessment
Publish Date: 2026-05-28 07:00:00
Source Domain: www.prnewswire.com
- Alife Health has received FDA clearance for its Embryo Predict tool, aimed at assisting fertility specialists in selecting embryos for in vitro fertilization (IVF).
- The tool uses artificial intelligence to analyze embryo images and generate an AI score, incorporating data from global embryo outcomes.
- A multi-center randomized clinical trial with 440 patients at seven U.S. centers validated the clinical effectiveness of the tool.
- The product is designed to provide adjunctive data to clinicians, especially in situations where multiple embryos are suitable for transfer or freezing.
- Embryo Predict is indicated for analyzing blastocyst-stage embryos at Day 5, 6, and 7, and is now commercially available in the U.S., Europe, and the U.K.
