CardioComm Solutions 'UmutimaCheck (TM) CardiBeat hamwe na Terefone Yubwenge Yinjiza Icyiciro cya nyuma cya FDA 510 (k) Isubiramo |Ecg Kurongora

Porogaramu 510 (k) yatangiye isuzuma ryiminsi 90 Substantive Review na FDA ku ya 8 kamena 2018. FDA yasabye amakuru 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 asabwa.

Kuri Medgadget turatanga amakuru kumakuru agezweho yubuhanga bwubuvuzi, kubaza abayobozi murwego, no kohereza dosiye mubikorwa byubuvuzi byo hirya no hino.

Muri ubu bushakashatsi, imyaka yatekerejweho igereranya ingano yisoko ryinsinga za Global ECG hamwe na ECG iyobora ni ibi bikurikira: Umwaka wamateka: 2013-2017 Umwaka shingiro: Umwaka uteganijwe: 2017 Umwaka uteganijwe 2018 kugeza 2025

Uturere twinshi two muri Reta zunzubumwe za Amerika Pulse Oximeter Sisitemu Inganda nizi zikurikira: Ubudage, Ubufaransa, Ubwongereza, Uburusiya, Ubutaliyani, Espagne, Benelux

Cerebral Oximetry Gukurikirana amarushanwa yisoko ryakozwe nabakora inganda zikomeye / Umukinnyi wingenzi / Ubukungu nabayobozi bashinzwe ubucuruzi: Medtronic, Philips Healthcare, Masimo, GE Healthcare, Edwards Lifesciences, Mindray Medical, Natus Medical, Honeywell Life Science, Welch Allyn, Omron Healthcare, Nihon Kohden, Spacelabs Ubuvuzi, Ubuvuzi bwa Mutagatifu Jude, Ubuvuzi bwa Nonin, Ubumenyi bwa Boston ,,.Ibindi ……

Rero hejuru yibice bivuguruzanya byinganda za Pulse Oximeter harimo urutonde rwinganda, gahunda, nuburyo bugaragara.Ihanagura kandi ingingo ngenderwaho nka sosiyete ya Pulse Oximeter itumanaho amakuru yerekeye itsinda ryinganda za Pulse Oximeter, ibyiciro, gutondekanya ibipimo, amafaranga yo kugurisha, igiciro / igiciro cyibicuruzwa bya Pulse Oximeter, hamwe nabacuruzi b'ingenzi.

Kuramo udutabo twa PDF ya Cable ya ECG na ECG Yayoboye insinga Raporo yubushakashatsi ku isoko @ https://www.coherentmarketinsights.com/insight/request-pdf/957

Hagati aho, kwemererwa na FDA Apple yatangaje ku wa gatatu bifitanye isano n'ibintu bibiri: Icya mbere ni uko isaha ishobora kugenzura umutima wawe injyana idasanzwe kandi igatanga integuza niba kandi ibimenye - iyi mikorere iraboneka kuri moderi zose za Apple Watch zikundana. gusubira ku mwimerere.

Ubushakashatsi bwakozwe burimo abashoferi b'isoko, bahari kimwe n'amahirwe yo gukura yegereje, igice cyubwenge hamwe n'akarere ibibazo byugarije ECG Cable na ECG Lead Wires isoko, ibintu birushanwe kumasoko yisi.Imiterere y'akarere ka raporo ikubiyemo ubunini bw'isoko no kugereranya uturere aribyo, Amerika y'Amajyaruguru, Uburayi, Aziya ya pasifika (APAC), Uburasirazuba bwo hagati na Afurika (MEA), na Amerika y'Epfo.

Nari nishimiye kurya indyo yuzuye mumashuri yubuvuzi kugeza mpuye numuntu udasanzwe.Gary Thomas yarantangaje kuva mpura nawe.Umwarimu wubuvuzi ufite ubuhanga, arashobora kukujyana murugendo ruva muri fiziki yibanze ukita ku mwana urwaye mu kanya nk'ako guhumbya.Mugihe cyo gusubiramo ikizamini cya anesthetic, yatanze imyitozo ya viva, nari ntegereje bidasanzwe.Nari naratsinze ibizamini byanjye byanditse, numva nizeye neza ubumenyi bwanjye, kandi nizeye ko nshobora kumushimisha.Iminsi mike mbere ya Noheri, ninjiye mu biro bya Gary mu isomo ryacu rya mbere.Isaha yakurikiyeho yari urujijo.Birashoboka ko nahagaritse ububabare mu mutwe.Kwibuka nagumanye ni ugusubiza ikibazo kijyanye n'ingaruka za termometero hamwe na "Nibyo, birashobora guturika!"Ntabwo nari narigeze nkora ibintu bitangaje gusa, ariko nta ihumure rya sandwich yo guhekenya.Ati: “Ibyo ntabwo ari byiza bihagije.Ugomba gukora imirimo myinshi kandi mu bundi buryo niba ushaka gutsinda. ”Natekereje nti: “Noheri nziza kuri njye.”

Imiyoboro yo kugurisha yahisemo (ikubiyemo ibicuruzwa bitaziguye kimwe n’ubucuruzi butaziguye) n’ibigo byabaruwe muri raporo.

Isoko ryo gukora ibyuma 2018 ryerekana umuvuduko witerambere kandi birashoboka ko ari imwe mu nganda zagize uruhare mu kuzamura ubukungu mpuzamahanga.…