Inkampani yakwa-Israel i-DarioHealth ifumene imvume ye-510 (k) yenguqu yenkqubo yokuhlola i-glucose yegazi ehambelana ne-iPhone 7, i-8 kunye ne-X kunye ne-app ye-Dario, ngokwengxelo yenkampani.
"Sisebenze ngokungakhathali ukufumana isisombululo esihlangabezana nemigangatho engqongqo efunekayo ukuze sifumane imvume ye-FDA," utshilo u-Erez Rafael, i-CEO kunye noSihlalo weDarioHealth.ukuvumela uninzi lwabasebenzisi bethu bangaphambili abaye bafudukela kwezi iPhones zintsha ukuba baphucule izakhono zabo zeDario.Oku kuyaqhubeka nenkqubela phambili yeDarioHealth kwimarike yase-US kwaye ivula ngokwenene umnyango wokwandiswa kwemarike.
Inkqubo yeDario inesixhobo sepokotho esibandakanya iglucometer, imichilo yovavanyo olulahlwayo, isixhobo sokuxhoma, kunye ne-app ye-smartphone ehamba nayo.
I-DarioHealth ekuqaleni ifumene imvume ye-FDA yenkqubo yokujonga isifo seswekile yedijithali ngoDisemba 2015, kodwa yabekwa ecaleni xa i-Apple ibhengeza isigqibo sayo esinempikiswano sokususa i-headphone jack ngenxa yokuxhomekeka kwe-hardware kwi-3.5mm ye-headphone jack.abavelisi besixhobo baxhasa kuphela isinxibelelanisi soMbane sombane se-Apple.
"Ezi ndaba [ukususwa kwe-3.5 mm jack] azizange zisimangalise, siye sasebenza kwisisombululo ixesha elide," kusho uRafael kwi-2016. imarike yezempilo.“
Inkqubo ye-DarioHealth ehambelana nombane ifumene uphawu lwe-CE ngo-Okthobha kwaye sele ikhona ukususela ngoSeptemba kwii-smartphones ezikhethiweyo ze-Android e-US, ezifana ne-Samsung Galaxy S series, i-Samsung Galaxy Note series, kunye ne-LG G series.Ukulandela imvume yamva nje, inkampani ithe ijonge ukwandisa intengiso yayo e-USA kwezi veki zizayo.
Ngexesha le-teleconference ngoNovemba ophelileyo, uRaphael waxoxa ngezihloko ezininzi ezibalulekileyo, kuquka ukuhambelana koMbane kunye nokwandisa ukuthengisa kwe-US.Amanye amagqabaza akhe abandakanya iingcinga zakhe malunga nokuqaliswa kweDarioHealth yeqonga elitsha leB2B yenkampani, uDario Engage, kwimarike yaseJamani.