Inkampani yakwa-Israyeli Dariohealth ithole imvume engu-510 (k) yenguqulo yohlelo lwayo lokuqapha i-glucose ehambisana ne-iPhone 7, 8 no-X kanye nohlelo lokusebenza lwe-Dario, ngokuya ngesitatimende senkampani.
"Sisebenze ngokungakhathali ukuthola isisombululo esihlangabezana nezindinganiso ezinzima ezidingekayo ukuze sithole imvume ye-FDA," kusho u-Erez Rafael, CEO noSihlalo weDarioHealth. Ukuvumela iningi labasebenzisi bethu bedlule abathuthele kulezi zephono ezintsha ukuze bathuthukise amakhono abo e-dario. Lokhu kuyaqhubeka ukuthuthuka kwe-DarioHealth eMakethe yase-US futhi kuvule ngempela umnyango wokunwetshwa kwamakethe okukhulu.
Uhlelo lwe-Dario luqukethe idivaysi ephaketheni efaka i-glucometer, imichilo yokuhlola elahlekile, idivaysi yokulayisha, nohlelo lokusebenza lwe-smartphone oluhambisana nalo.
I-DarioHealalth ekuqaleni ithole imvume ye-FDA yohlelo lokuqapha isifo sikashukela sedijithali ngoDisemba 2015, kodwa yahlukaniswa lapho i-apula imemezela isinqumo salo esiphikisanayo sokususa i-headphone jack ngenxa ye-hardware i-jackphonephonephone ye-3.5mm. Abakhiqizi bedivayisi baxhasa kuphela isixhumi sombani se-Apple Propriention.
"Lezi zindaba [ukususwa kukaJack ka-3.5 mm] azange zizenze isimanga ngesixazululo isikhathi eside," kusho uRafael ngonyaka we-2016. Imakethe yezempilo. "
Uhlelo oluhambisanayo oluhambelana no-DARIOHealth System luthole ukuphaka ngo-Okthoba futhi selutholakale kusukela ngoSepthemba ku-Khetha ama-Smartphones e-US e-US, njengochungechunge lwe-Samsung Galaxy S. Ngemuva kokuthola imvume yakamuva yamasiko, inkampani ithe ihlose ukukhulisa ukuthengisa kwayo ku-USA emasontweni azayo.
Ngesikhathi se-teleconfer ngoNovemba, uRaphael waxoxa ngezihloko eziningana ezibalulekile, kufaka phakathi ukuhambisana kombani nokwandisa ukuthengisa kwe-US. Okunye ukuphawula kwakhe kwakuhlanganisa imicabango yakhe ngokwethulwa kwe-dariohealth yepulatifomu entsha ye-B2B yenkampani, i-dario ehlanganyela emakethe yaseJalimane.