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EM-LUX ยท INVESTIGATIONAL

Em-Lux benchtop imaging system

Em-Lux is a benchtop fluorescence lifetime imaging system. It images each embryo in its dish without dyes or contact, and EMMI, our algorithm, reports a score for each one. Not FDA cleared.

Em-Lux benchtop instrument with its imaging dish drawer open
THE INSTRUMENT

The instrument

Benchtop

A single benchtop unit for the embryology lab.

Completely non-invasive

Measures natural fluorescence. No dyes, stains or biopsy.

Imaging dish

Embryos are imaged in a single-use imaging dish.

Lifetime measurement

Fluorescence lifetime does not depend on signal brightness, which reduces sensitivity to optical setup.

Em-Lux 1.0 prototype on an inverted microscope
Em-Lux 1.0, installed on a standard inverted microscope
Em-Lux 1.0 running at a partner site
Em-Lux 1.0 at a partner site
WORKFLOW AND REPORT

From loading the dish to the report

Em-Lux software showing an EMMI score and lifetime map for each embryo
Em-Lux software: the report view
  1. 01
    Set upSelect the patient and load the dish.
  2. 02
    LocateEm-Lux finds each embryo in the dish.
  3. 03
    AcquireBrightfield and metabolic images are captured for each one.
  4. 04
    ReportEach embryo receives an EMMI category (Low, Moderate or High) with its metabolic image. Embryos can be sorted by score, and the embryologist reviews.

EMMI is decision support. Final clinical decisions stay with qualified embryologists and physicians.

EMMI ALGORITHM

Embryo Morpho-Metabolic Index

EMMI is our proprietary algorithm. It is designed to weigh metabolic endpoints from Em-Lux together with morphology and clinical factors, assign each embryo a Low, Moderate or High category, and rank the cohort.

Diagram: EMMI combines metabolism, morphology and patient data, groups embryos by likely viability, then ranks them
Three inputs, one category per embryo. Step 1 is designed to separate embryos with higher and lower likely viability. Step 2 ranks them so the embryologist can see which to review first. Illustrative example.

Inputs and outputs

InputsNADH fluorescence lifetime; morphology (shape, size, grade); patient age and clinical history
RegionInner cell mass and whole embryo
OutputLow, Moderate or High category per embryo, and a ranking within the cohort
Quality controlAutomatic image quality check; no score if it fails
VersioningModel version locked before validation, with an audit trail
AI

How EMMI uses AI

Each scan goes through six steps, from image capture to a score with an explanation. The lifetime measurement is calibrated with physics, using no learned parameters, before the AI steps run. The embryologist makes the final decision.

Animation: EMMI locates the inner cell mass, extracts lifetime features, combines them with morphology and patient factors, checks image quality and assigns a category

Processing steps

  1. STEP 1AcquireLifetime and brightfield images
  2. STEP 2CheckAutomatic quality gate
  3. STEP 3CalibratePhysics layer, no learned parameters
  4. STEP 4LocateInner cell mass region
  5. STEP 5QuantifyMetabolic and morphologic features
  6. STEP 6ScoreEMMI score with explanation

FAQ

Is Em-Lux FDA cleared?

No. Em-Lux and EMMI are investigational and are not cleared or approved by the FDA.

Has the effect of imaging on embryos been studied?

Imaging safety has been studied in human embryos, and the results have been submitted for peer review. These are research data only. They have not been reviewed by the FDA.

Does it replace PGT-A?

No. PGT-A tests chromosomes and requires a biopsy. Em-Lux measures metabolism without contact. We expect them to be used together.

Can it assess eggs?

Egg assessment is in development with our academic partners and is not yet part of the product.

NEXT

See where Em-Lux fits in your lab

Compare Em-Lux with grading, time-lapse and PGT-A, and see how clinics can take part in our clinical study.

For clinicsContact us