Sight Diagnostics launches new POC system
Sight Diagnostics, an Israeli medical devices startup that uses computer vision and machine learning technology to speed up blood testing, is launching a point-of-care (POC) blood diagnostics system. OLO is an AI-based blood diagnostics device which offers lab-quality Complete Blood Count (CBC) tests from finger prick samples at the point-of-care. The company also announced the completion of a 287-person clinical trial at Israel’s Shaare Zedek Medical Centre, which led to a CE Mark registration for OLO. This European regulatory certification indicates OLO’s conformity with high safety, health, and environmental protection standards and allows for commercial sale in countries that require CE marking. Sight recently began clinical trials in the US to study OLO’s clinical performance and obtain FDA approval, with sites at Boston Children’s Hospital and Columbia University Irving Medical Center. Sight plans to pursue initial US clearance for use in qualified laboratories, to be followed by a subsequent waiver application to allow broader use at the POC.