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DarioHealth waxay siisaa Apple hillaaca ku habboon 510 (k) mitirka gulukooska dhiigga

Shirkadda Israa’iil ee DarioHealth ayaa heshay oggolaansho 510 (k) ah nooca nidaamka la socodka gulukooska dhiigga ee ku habboon iPhone 7, 8 iyo X oo ay weheliso app-ka Dario, sida lagu sheegay bayaan shirkadeed.
"Waxaan u shaqeynay si aan daalin lahayn si aan u helno xal buuxiya heerarka adag ee loo baahan yahay si loo helo oggolaanshaha FDA," ayuu yiri Erez Rafael, Maamulaha Guud iyo Guddoomiyaha DarioHealth.u ogolaanaya qaar badan oo ka mid ah isticmaalayaashayadii hore ee u haajiray iPhone-kan cusub si ay kor ugu qaadaan awoodooda Dario.Tani waxay sii waddaa horumarka DarioHealth ee suuqa Maraykanka oo runtii albaabka u furaysa balaadhinta suuqa.
Nidaamka Dario waxa uu ka kooban yahay qalab jeebka ah oo ay ku jiraan glucometer, xariijimaha tijaabada ee la tuuri karo, qalabka daloolinta, iyo abka casriga ah ee la socda.
DarioHealth waxay markii hore heshay ogolaanshaha FDA ee nidaamka la socodka sonkorowga dhijitaalka ah bishii Diseembar 2015, laakiin waa laga saaray markii Apple ay ku dhawaaqday go'aankeeda muranka dhaliyay ee ah inay ka saarto jaakadda dhegaha sababtoo ah ku tiirsanaanta qalabka qalabka dhegaha ee 3.5mm.Soosaarayaasha aaladaha waxay taageeraan xiriiriyaha hillaaca gaarka ah ee Apple.
"Warkan [ka-saarida jaakada 3.5 mm] ma ahan mid la yaab leh annaga, waxaan ka shaqeyneynay xal muddo dheer," Rafael ayaa yiri 2016. Suuqa daryeelka caafimaadka."
Nidaamka DarioHealth ee ku habboon hillaaca waxa uu helay calaamadaynta CE bishii Oktoobar waxaana laga helayaa tan iyo Sebtembar taleefannada casriga ah ee Android ee gudaha Mareykanka, sida taxanaha Samsung Galaxy S, taxanaha Samsung Galaxy Note, iyo taxanaha LG G.Ka dib markii dhawaan kastamka la fasaxay, shirkaddu waxay sheegtay inay ku talo jirto inay balaariso iibkeeda USA toddobaadyada soo socda.
Intii lagu guda jiray kulan teleefan bishii Nofembar ee la soo dhaafay, Raphael wuxuu ka hadlay dhowr mowduuc oo muhiim ah, oo ay ku jiraan waafaqid Hillaaca iyo ballaarinta iibka Mareykanka.Faallooyinkiisii ​​kale waxaa ka mid ahaa fikirradiisii ​​ku aaddanaa DarioHealth ee bilaabay shirkadda cusub ee B2B, Dario Engage, ee suuqa Jarmalka.


Waqtiga boostada: Juun-19-2023