Obstetrics_gynecology

Embryo Predict

Alife Health

CEFDAUKCA
FDA-cleared AI medical device

Software that analyses images of day 5, 6 and 7 blastocyst-stage embryos cultured in vitro that an embryologist has already deemed suitable for transfer. Using patient age and day of culture together with an algorithm that analyses blastocyst morphology, it provides adjunctive information to aid the assessment of blastocysts when several embryos are suitable for transfer or freezing on standard morphological assessment. It is intended for analysis before biopsy and cryopreservation.

FDA Submission Metadata

Submission number
K250781
Decision date
May 2026
FDA panel
Obstetrics and Gynecology
Product code
PBH

This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.

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Regulatory Approvals

CE
CE marking under the EU MDR — EUDAMED Class IIa registration (basic UDI-DI 08600089872HERARB)

Class IIa

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FDA
Embryo Predict — 510(k) clearance (product code PBH)

K250781

Class II

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UKCA
Embryo Predict — MHRA PARD registration, Class IIa (GMDN 61087)

Class IIa

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