Ua loaʻa i ka hui Israeli DarioHealth kahi ʻae 510 (k) no kahi mana o kāna ʻōnaehana nānā glucose koko i kūpono me ka iPhone 7, 8 a me X me ka polokalamu Dario, e like me ka ʻōlelo a ka hui.
"Ua hana luhi mākou no ka loaʻa ʻana o kahi hopena e kū ana i nā kūlana koʻikoʻi e koi ʻia e loaʻa ka ʻae FDA," wahi a Erez Rafael, Luna Nui a me ka luna o DarioHealth.e ʻae ana i ka nui o kā mākou mea hoʻohana i hala i neʻe i kēia mau iPhones hou e hoʻonui i kā lākou mau mana Dario.Ke hoʻomau nei kēia i ka holomua o DarioHealth i ka mākeke US a wehe maoli i ka puka i ka hoʻonui nui ʻana o ka mākeke.
Aia ka ʻōnaehana Dario i kahi mea ʻeke e komo pū ana me kahi glucometer, nā ʻāpana hoʻāʻo hoʻopau ʻia, nā mea lancing, a me kahi polokalamu kelepona.
Ua loaʻa mua ʻo DarioHealth i ka ʻae FDA no kahi ʻōnaehana nānā ʻana i ka maʻi diabetes i ka mahina ʻo Dekemaba 2015, akā ua haʻalele ʻia i ka wā i hoʻolaha ai ʻo Apple i kāna hoʻoholo hoʻopaʻapaʻa e wehe i ke poʻo poʻo ma muli o ka hilinaʻi ʻana i ka mīkini i ka jack headphone 3.5mm.Kākoʻo wale nā mea hana mea hana i ka mea hoʻohui Lightning proprietary o Apple.
"ʻO kēia nūhou [ka wehe ʻana i ka 3.5 mm jack] ʻaʻole ia he mea kupanaha iā mākou, ua hana mākou i kahi hopena no ka manawa lōʻihi," i ʻōlelo ai ʻo Rafael ma 2016. mākeke mālama olakino.“
Ua loaʻa i ka ʻōnaehana DarioHealth hiki ke Uila i ka hōʻailona CE i ʻOkakopa a ua loaʻa iā ia mai Kepakemapa ma nā kelepona Android koho ma US, e like me ka Samsung Galaxy S series, Samsung Galaxy Note series, a me LG G series.Ma hope o ka hoʻokuʻu ʻana i nā kuʻuna, ua ʻōlelo ka ʻoihana e hoʻonui i kāna kūʻai aku i USA i nā pule e hiki mai ana.
I ka wā teleconference i Nowemapa i hala, ua kūkākūkā ʻo Raphael i kekahi mau kumuhana koʻikoʻi, me ka hoʻohālikelike ʻana o Lightning a me ka hoʻonui ʻana i ke kūʻai aku ʻana o US.ʻO kāna mau ʻōlelo ʻē aʻe i pili i kona mau manaʻo i ka hoʻolaha ʻana o DarioHealth i ka kahua B2B hou o ka hui, ʻo Dario Engage, ma ka mākeke Kelemania.
Ka manawa hoʻouna: Iune-19-2023