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
New tool gives fertility clinicians an adjunctive data-driven layer of insight for one of IVF’s most critical decisions, supported by a multi-center randomized clinical trial
SAN FRANCISCO, May 28, 2026 /PRNewswire/ — Alife Health, a digital health company advancing fertility care through artificial intelligence, today announced that its product Embryo Predict has received clearance from the U.S. Food and Drug Administration (FDA). The clearance covers the use of Embryo Predict to help fertility specialists evaluate and select embryos for transfer during in vitro fertilization (IVF), one of the most consequential decisions in the IVF process.
IVF is one of the most emotionally and financially demanding medical journeys a person can take, with patients in the U.S. undergoing an average of three cycles before a successful pregnancy. A significant factor is the complexity of choosing which embryo to transfer. 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[1]. Even among the most experienced clinicians, this evaluation has remained largely a matter of individual judgment.
Embryo Predict uses artificial intelligence to analyze images of each embryo and generate an AI score. The AI draws on patterns learned from thousands of embryos and their outcomes across clinics, geographies, and patient profiles worldwide. It integrates with the microscopes and imaging systems already in use in fertility labs, with no new hardware required.
The FDA clearance was supported by a prospective, randomized, multi-center clinical trial, that was conducted at seven leading centers across the United States. The trial enrolled 440 patients across seven U.S. clinics and evaluated the use of AI-assisted embryo selection compared to standard evaluation alone.
“Six years ago, we set out to…
