Gusaba raporo yintangarugero:
Porogaramu 510 (k) yatangije isuzuma ryayo ryiminsi 90 na FDA ku ya 8 kamena 2018. FDA yasabye andi makuru yinyongera muri Sosiyete yerekeranye nigikoresho cyo ku ya 27 Nyakanga 2018, gihagarika isaha kumurongo wa Substantive Review.Kubara iminsi 90 bizongera gutangira FDA yemera igisubizo cyisosiyete kumakuru yinyongera yasabwe.
Apple Watch Series 4 izaba ifite ubushobozi bwo kubika amakuru yo gusuzuma EKG kubikoresho kandi bizagerwaho binyuze muri porogaramu ya HealthKit ikorera kuri iPhone.Nubwo tutarabona verisiyo yanyuma yiyi porogaramu, herekanywe ko amakuru ashobora gusangirwa gusa na muganga binyuze mumikorere yohereza hanze.
Amajyaruguru ya Amerika (Igihugu) Aziya-Pasifika (Igihugu) Uburayi (Igihugu) Hagati & Amerika yepfo (Igihugu) Uburasirazuba bwo hagati & Afurika (Igihugu)
Toronto, Ontario, 23 Ugushyingo 2018 (Newsfile Corp ibinyujije kuri COMTEX) - CardioComm Solutions, Inc. (EKG) hamwe no gucunga software ikemura, yarangije igisubizo cyayo muri Amerika ishinzwe ibiryo n'ibiyobyabwenge ("FDA") kubindi bisobanuro nyuma yisosiyete itanga imenyekanisha ryayo rya mbere 510 (k), icyiciro cya kabiri cyo kuvura ibikoresho byubuvuzi bya HeartCheck ™ CardiBeat na GEMS Application Porogaramu igendanwa.
Inzozi mbi ya kabili benshi muritwe uyumunsi nukuri.Kubwanjye, kubera ko ndi umukoresha wa Android na iOS, ngomba gutwara (byibuze) ubwoko butandatu bwinsinga hagati yimifuka yanjye n imodoka yanjye igihe cyose:
Mugusuzuma aya magambo, abasomyi ntibagomba kwishingikiriza bidakwiye kumagambo areba imbere hamwe namakuru areba imbere.Isosiyete ntisabwa inshingano zo kuvugurura ibyarebaga imbere hamwe namakuru areba imbere bikubiye muri iri tangazo usibye nkuko bisabwa n'amategeko akurikizwa, harimo nta mbogamizi, Igice cya 5.8 (2) cyigikoresho cyigihugu 51-102 (Inshingano Zikomeza Kumenyekanisha ).
Abashakashatsi bareba imiterere yubucuruzi bagamije kwerekana imibare yingenzi kubijyanye nimiterere nyayo yisoko ryagenewe n'aho amahirwe mashya ari.Ibyatanzwe muburyo bugenda buhinduka nibitandukaniro kumasoko bigize igice cyingenzi cyubushakashatsi.Ubushakashatsi ku bidukikije burakubiyemo amakuru ajyanye n’amabwiriza ya leta, demografiya, imigendekere yisoko nubunini hamwe nuburyo butandukanye bwo kwamamaza.
Indi miterere ishobora kugaragara hamwe nubushobozi bwo kwiga imashini ya AliveCor ni hyperkalemia, ikaba yongereye urugero rwa potasiyumu mumaraso kandi mubisanzwe ntabwo ari ibimenyetso kandi biragoye kuyisuzuma.Ifitanye isano n'ingaruka mbi nko kunanirwa k'umutima, diyabete, n'indwara zidakira.
Isoko rya pulse oximeter kwisi yose hamwe na Amerika ya ruguru kandi ryagize imigabane igera kuri 40% yinjiza yose yinjije mumwaka wa 2016. Iri terambere rishobora guterwa no kuba hari abakinnyi bakomeye, hamwe nubuzima bwiza mubantu.Ubwiyongere kandi buterwa nindwara nyinshi zubuhumekero nubwiyongere bwabaturage bakuze muri kano karere.Uburayi nandi masoko akomeye mukarere akurikirwa na Amerika ya ruguru bitewe nubuvuzi buhanitse bwo kwivuza, ibigo byita ku barwayi.Aka karere gafite byinshi byo gutanga, kubera ko abaturage bafite ubuzima bwiza kandi bafite umuvuduko wihuse wibikoresho byubuvuzi mubuzima bwa buri munsi.Aziya ya pasifika yari isoko ryihuta cyane kubera ubwiyongere bwabaturage, amafaranga yinjira menshi hamwe no gukoresha amafaranga y’abaguzi mu kwivuza.Aka karere kateye imbere cyane kubera ingamba zafashwe n’inzego za Leta mu gukangurira abantu no gukoresha ibikoresho by’ubuvuzi mu bitaro no mu bigo nderabuzima.
ECG Cable na ECG Iyobora insinga Isoko ikubiyemo isesengura ryuruhererekane rwinganda, ikoranabuhanga ryinganda, ibiranga nibigezweho byamasoko & dinamike yibanda kubizaza hamwe nibisabwa, igiciro no kwagura isoko, ibiciro, irushanwa, ingano, ibiciro nuruhererekane rwagaciro rwabakinnyi bakomeye muri isoko.Raporo yisoko rya ECG Cable na ECG Lead Wires yerekana isoko ryagurishijwe ninganda kwisi yose hamwe namasosiyete, uturere, ubwoko hamwe nibisabwa hamwe nu iteganyagihe kugeza 2026. Iyi raporo yiga kandi uko isoko ryifashe ku isi, imiterere y’irushanwa, umugabane w’isoko, umuvuduko w’iterambere, ibizaza, abashoferi b'isoko, amahirwe n'imbogamizi, imiyoboro yo kugurisha, abakwirakwiza hamwe na Porter's Five Force Isesengura.
Isi yose ya ECG Cable na ECG Yayoboye insinga Raporo yisoko itanga isesengura ryuzuye rya: ??ECG Cable na ECG Iyobora insinga inganda ??Iperereza ryinganda na Downstream ??Ingaruka yubukungu iranga kwisuzumisha ??Imiyoboro hamwe nibitekerezo byemewe ??Amarushanwa yo kwisoko nabakinnyi ??Ikizamini cyo kunoza ibyifuzo
Impano Ibi, Ntabwo aribyo: Garmin Fenix 5 Plus na Apple Reba Nike + Urukurikirane 4 |Cable Cable Cable Cable Video:
Buri munyamuryango kuva murwego rwo hejuru rwo kugurisha aha agaciro ibyo abakiriya bakeneye no gutumanaho mubucuruziAmaraso Yamaraso Kubakurikirana abarwayi , Imashini ya Spo2 , Nellcor Ikoreshwa rya Spo2 Sensor N25, Nyamuneka umva kubusa kutwoherereza ibisobanuro byawe tuzagusubiza asap.Dufite itsinda ryubwubatsi bwumwuga kugirango dukorere buri kintu gikenewe.Ibyitegererezo byubusa birashobora koherezwa kubwawe kugirango umenye byinshi byukuri.Kugirango ubashe guhaza ibyifuzo byawe, nyamuneka rwose wumve ko nta kiguzi watwandikira.Urashobora kutwoherereza imeri hanyuma ukaduhamagara neza.Byongeye kandi, twishimiye gusura uruganda rwacu kuva kwisi yose kugirango tumenye neza ikigo cyacu.nd ibicuruzwa.Mu bucuruzi bwacu n'abacuruzi bo mu bihugu byinshi, akenshi dukurikiza ihame ry'uburinganire n'inyungu.Ni ibyiringiro byacu byo kwisoko, kubufatanye, ubucuruzi nubucuti kubwinyungu zacu.Dutegereje kubona ibibazo byawe.