Sight Di­ag­nos­tics launches new POC sys­tem

BioSpectrum (Asia) - - Start-up News -

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.

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