Kampani yaku Israeli ya DarioHealth yalandila chivomerezo cha 510(k) cha mtundu wa makina ake owunika shuga m'magazi omwe amagwirizana ndi iPhone 7, 8 ndi X pamodzi ndi pulogalamu ya Dario, malinga ndi zomwe kampaniyo inanena.
"Tagwira ntchito molimbika kuti tipeze yankho lomwe likugwirizana ndi mfundo zokhwima zomwe zimafunikira kuti tipeze chivomerezo cha FDA," adatero Erez Rafael, CEO ndi Chairman wa DarioHealth.kulola ogwiritsa ntchito athu ambiri akale omwe adasamukira ku ma iPhones atsopanowa kuti akweze luso lawo la Dario.Izi zikupitiliza kupita patsogolo kwa DarioHealth pamsika waku US ndipo zimatseguladi chitseko chakukulitsa msika.
Dongosolo la Dario lili ndi kachipangizo ka m'thumba komwe kumaphatikizapo glucometer, mizere yoyesera yotayira, chipangizo cholumikizira, ndi pulogalamu yam'manja yam'manja.
DarioHealth poyambilira idalandira chilolezo cha FDA panjira yowunikira matenda a shuga mu Disembala 2015, koma idayikidwa pambali pomwe Apple idalengeza lingaliro lake lotsutsana lochotsa jackphone yam'mutu chifukwa chodalira zida zam'mutu za 3.5mm.opanga zida amangothandizira cholumikizira cha mphezi cha Apple.
"Nkhani iyi [kuchotsedwa kwa 3.5 mm jack] sikunadabwe kwa ife, takhala tikugwira ntchito yothetsera vutoli kwa nthawi yaitali," adatero Rafael mu 2016. msika wa zaumoyo.“
Dongosolo logwirizana ndi Mphezi la DarioHealth lidalandira chizindikiro cha CE mu Okutobala ndipo lakhala likupezeka kuyambira Seputembala pama foni osankhidwa a Android ku US, monga mndandanda wa Samsung Galaxy S, Samsung Galaxy Note series, ndi LG G series.Kutsatira chilolezo chaposachedwa, kampaniyo idati ikufuna kukulitsa malonda ake ku USA m'masabata akubwera.
Pa teleconference mu Novembala watha, Raphael adakambirana mitu ingapo, kuphatikiza kuyanjana kwa Mphezi ndikukulitsa malonda aku US.Ndemanga zake zina zidaphatikizapo malingaliro ake pa DarioHealth kukhazikitsidwa kwa nsanja yatsopano ya B2B ya kampani, Dario Engage, pamsika waku Germany.
Nthawi yotumiza: Jun-19-2023