Alife Health has received US FDA clearance for Embryo Predict, an AI-powered tool designed to support embryo assessment and selection during in vitro fertilisation.

The clearance addresses a high-stakes decision point in IVF, where embryo selection can influence treatment timelines, patient cost and emotional burden. Fertility care remains complex, and patients in the United States undergo an average of three IVF cycles before a successful pregnancy.

Embryo Predict uses artificial intelligence to analyse images of blastocyst-stage embryos and generate an AI score. The tool is indicated for Day 5, 6 and 7 embryos that have already been deemed suitable for transfer by an embryologist, providing adjunctive information when multiple embryos are suitable for transfer or freezing.

The FDA clearance was supported by a prospective, randomised, multicentre clinical trial conducted at seven US centres and involving 440 patients. Alife also cited published research showing a 34.6 percent disagreement rate among fertility specialists selecting the top embryo for transfer, rising to 44 percent when patients had three or more embryos.

A key differentiator is workflow compatibility. Embryo Predict integrates with microscopes and imaging systems already used in fertility laboratories, requiring no new hardware. The tool has also received CE Mark under the European Union Medical Device Regulation and is commercially available in the US, Europe and the UK.

Adoption will depend on clinician trust, laboratory workflow fit, evidence of incremental value, regulatory expectations and how fertility centres position AI as an adjunct rather than a replacement for embryologist expertise. Patient communication will also be important, given the sensitivity of IVF decision-making. As reproductive medicine becomes more data-driven, AI tools that improve consistency while preserving clinical oversight may become increasingly relevant.