Sight’s POC blood diagnostic OLO gets 510(k) clearance

February 5, 2020 0 By FM

Sight Diagnostics received a 510(k) clearance from USFDA for its point-of-care blood diagnostic device, OLO, which uses artificial intelligence to optically read small amounts of blood and provide complete blood count tests during a single doctor’s visit.

After taking two drops of blood from a finger prick or venous draw, a physician can place them into a self-contained, disposable cartridge, which is then fed into the tabletop machine. Test results are then displayed on a screen within minutes.

The compact device uses digital microscopes to visually tally the number of red blood cells, white blood cells and platelets found in a sample to provide physicians with a quick overview of a patient’s general health. The panel is included in over 90% of baseline blood tests.

Sight’s algorithms draw from nearly half a petabyte of blood image data collected over five years of clinical work, the company said, with OLO analyzing 19 parameters to provide a full blood count and flag certain clinical abnormalities.

The OLO has been commercially available in Europe and other international markets since it obtained a CE mark in July 2018.