FDA-Cleared AI Device

Sight OLO

Sight Diagnostics

A point-of-care hematology analyzer using digital microscopy and machine vision to produce a complete blood count from a small blood sample without a laboratory.

At A Glance

Manufacturer
Sight Diagnostics
Medical specialty
Primary Care and Laboratory
Clearance route
510(k)
Year authorized
2019
Modality
Digital microscopy
Role in workflow
Laboratory analysis

The interesting displacement is not the pathologist. It is the impedance-based hematology analyzer, a mature and reliable technology. Machine vision on actual cell images competes on sample volume and setting rather than on accuracy, which is why this ends up in a clinic rather than a laboratory.

Where It Is Used

  • Point-of-care CBC in clinics and urgent care
  • Pediatric testing with small sample volumes
  • Decentralized testing where laboratory access is limited

Limitations Worth Knowing

Point-of-care analyzers cover a defined parameter set and refer abnormal or flagged samples onward. Small-volume capillary sampling is more prone to collection artifact than venous draws, and that artifact does not announce itself in the result.

Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.