Inkampani yakwa-Israel i-DarioHealth ithole imvume engu-510(k) yenguqulo yohlelo lwayo lokuhlola ushukela wegazi elihambisana ne-iPhone 7, 8 kanye no-X kanye nohlelo lokusebenza lwe-Dario, ngokusho kwesitatimende senkampani.
"Sisebenze ngokuzikhandla ukuthola isisombululo esihlangabezana nezindinganiso ezinzima ezidingekayo ukuze sithole imvume ye-FDA," kusho u-Erez Rafael, oyi-CEO kanye noSihlalo we-DarioHealth.ukuvumela abasebenzisi bethu abaningi bangaphambilini abathuthele kulawa ma-iPhone amasha ukuze bathuthukise amakhono abo e-Dario.Lokhu kuqhubekisela phambili inqubekelaphambili ye-DarioHealth emakethe yase-US futhi kuvula ngempela umnyango wokwanda okukhulu kwemakethe.
Uhlelo lwe-Dario luqukethe i-pocket device ehlanganisa i-glucometer, imichilo yokuhlola elahlwayo, idivayisi yokukala, kanye nohlelo lokusebenza lwe-smartphone oluhambisana nalo.
I-DarioHealth ekuqaleni yathola imvume ye-FDA yohlelo lokuqapha isifo sikashukela ngo-December 2015, kodwa yabekwa eceleni lapho i-Apple imemezela isinqumo sayo esiyimpikiswano sokususa i-headphone jack ngenxa yokuthembela kwehadiwe ku-3.5mm jack headphone jack.abakhiqizi bedivayisi basekela kuphela isixhumi esiphathelene ne-Apple Lightning.
"Lezi zindaba [ukususwa kwe-3.5 mm jack] azizange zisimangaze, sesisebenze isikhathi eside ngesisombululo," kusho u-Rafael ku-2016. imakethe yokunakekelwa kwezempilo.“
Isistimu ye-DarioHealth ehambisana nombani ithole ukumaka i-CE ngo-Okthoba futhi ibilokhu itholakala kusukela ngoSepthemba kuma-smartphones akhethiwe e-Android e-US, njengochungechunge lwe-Samsung Galaxy S, uchungechunge lwe-Samsung Galaxy Note, nochungechunge lwe-LG G.Ngemuva kokugunyazwa kwakamuva kwe-custom, inkampani ithe ihlose ukwandisa ukuthengisa kwayo e-USA emasontweni ezayo.
Ngesikhathi se-teleconference ngoNovemba odlule, u-Raphael waxoxa ngezihloko ezimbalwa ezibalulekile, okuhlanganisa ukuhambisana kombani nokwandisa ukuthengisa kwe-US.Okunye ukuphawula kwakhe kuhlanganisa nemicabango yakhe mayelana nokwethulwa kukaDarioHealth kwenkundla entsha yenkampani i-B2B, i-Dario Engage, emakethe yaseJalimane.