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DarioHealth Yana Samar da Apple Walƙiya Mai jituwa 510 (k) Mitar Glucose na Jini

Kamfanin DarioHealth na Isra'ila ya sami amincewar 510 (k) don sigar tsarin sa ido kan glucose na jini wanda ya dace da iPhone 7, 8 da X tare da app na Dario, a cewar sanarwar kamfanin.
Erez Rafael, Shugaba da Shugaban DarioHealth ya ce "Mun yi aiki ba tare da gajiyawa ba don nemo mafita wanda ya dace da tsauraran matakan da ake buƙata don samun amincewar FDA."ƙyale yawancin masu amfani da mu na baya waɗanda suka yi ƙaura zuwa waɗannan sabbin iPhones don haɓaka damar Dario.Wannan yana ci gaba da ci gaban DarioHealth a cikin kasuwar Amurka kuma yana buɗe kofa ga fa'ida mai yawa na kasuwa.
Tsarin Dario ya ƙunshi na'urar aljihu da ta haɗa da glucometer, ɗigon gwajin da za a iya zubarwa, na'urar lancing, da kuma ƙa'idar wayar hannu.
DarioHealth da farko ya karɓi izinin FDA don tsarin kula da ciwon sukari na dijital a cikin Disamba 2015, amma an yi watsi da shi lokacin da Apple ya sanar da shawararsa mai rikitarwa don cire jack ɗin lasifikan kai saboda dogaro da hardware akan jackphone na 3.5mm.Masu kera na'ura suna tallafawa mahaɗin walƙiya na mallakar Apple kawai.
"Wannan labari [cire jack na 3.5 mm] bai zo mana da mamaki ba, mun dade muna aiki kan mafita," in ji Rafael a cikin 2016. Kasuwar kiwon lafiya."
Tsarin DarioHealth mai dacewa da walƙiya ya sami alamar CE a cikin Oktoba kuma yana samuwa tun watan Satumba akan zaɓin wayowin komai da ruwan Android a Amurka, kamar jerin Samsung Galaxy S, jerin Samsung Galaxy Note, da jerin LG G.Biyo bayan amincewar kwastam na baya-bayan nan, kamfanin ya ce yana da niyyar fadada siyar da shi ga Amurka nan da makonni masu zuwa.
A yayin taron wayar tarho a watan Nuwamban da ya gabata, Raphael ya tattauna batutuwa masu mahimmanci, gami da daidaitawar walƙiya da faɗaɗa tallace-tallacen Amurka.Sauran maganganunsa sun haɗa da tunaninsa game da ƙaddamar da DarioHealth na sabon tsarin kamfanin na B2B, Dario Engage, a cikin kasuwar Jamus.


Lokacin aikawa: Juni-19-2023