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DarioHealth Inopa Apple Mheni Inoenderana 510(k) Ropa Glucose Meter

Kambani yeIsrael DarioHealth yakagamuchira 510 (k) mvumo yeshanduro yeropa rekutarisa glucose system inoenderana neiyo iPhone 7, 8 uye X pamwe neDario app, sekureva kwekambani.
"Takashanda nesimba kuti tiwane mhinduro inoenderana neyakaomarara miyero inodiwa kuti tiwane mvumo yeFDA," akadaro Erez Rafael, CEO uye Sachigaro weDarioHealth.kubvumira vazhinji vevashandisi vedu vekare vakatamira kune aya maPhones matsva kukwidziridza kugona kwavo kweDario.Izvi zvinoenderera mberi nekufambira mberi kweDarioHealth mumusika weUS uye zvinovhura musuwo wekuwedzera kukuru kwemusika.
Iyo Dario sisitimu ine mudziyo wehomwe unosanganisira glucometer, inoraswa bvunzo mitsetse, lancing mudziyo, uye inoperekedza smartphone app.
DarioHealth pakutanga yakagamuchira FDA mvumo yedhijitari yekutarisa chirwere cheshuga muna Zvita 2015, asi yakamiswa apo Apple yakazivisa danho rayo rine gakava rekubvisa jackphone yemusoro nekuda kwekutsamira kwehardware pane 3.5mm headphone jack.vagadziri vemidziyo vanongotsigira Apple's proprietary Lightning connector.
"Iyi nhau [kubviswa kwe 3.5 mm jack] haina kuuya sechishamiso kwatiri, tave tichishanda pakugadzirisa kwenguva yakareba," akadaro Rafael mu 2016. misika yehutano.“
Iyo Mheni-inoenderana DarioHealth sisitimu yakagamuchira CE yekumaka muna Gumiguru uye yave kuwanikwa kubva munaGunyana pane yakasarudzwa Android smartphones muUS, senge Samsung Galaxy S series, Samsung Galaxy Note series, uye LG G series.Kutevera kubvumidzwa kwetsika nguva pfupi yadarika, kambani yakati ine chinangwa chekuwedzera kutengesa kwayo kuUSA mumavhiki anouya.
Munguva yetereconference munaNovember wapfuura, Raphael akakurukura nyaya dzakati wandei, kusanganisira Mheni kuenderana uye kuwedzera kutengesa kweUS.Mamwe matauriro ake aisanganisira pfungwa dzake pamusoro pekutanga kweDarioHealth kwekambani itsva B2B platform, Dario Engage, mumusika weGermany.


Nguva yekutumira: Jun-19-2023