{"id":20412,"date":"2024-03-30T10:23:50","date_gmt":"2024-03-30T13:23:50","guid":{"rendered":"https:\/\/www.guiafacilbrasil.com.br\/blog\/?p=20412"},"modified":"2024-03-30T10:23:50","modified_gmt":"2024-03-30T13:23:50","slug":"anvisa-faz-alerta-importante-sobre-relogios-inteligentes-veja","status":"publish","type":"post","link":"https:\/\/www.guiafacilbrasil.com.br\/blog\/anvisa-faz-alerta-importante-sobre-relogios-inteligentes-veja\/","title":{"rendered":"ANVISA faz alerta importante sobre rel\u00f3gios \u201cinteligentes\u201d; VEJA"},"content":{"rendered":"<p><img loading=\"lazy\" class=\"alignnone size-medium wp-image-20413\" src=\"https:\/\/www.guiafacilbrasil.com.br\/blog\/wp-content\/uploads\/2024\/03\/ANVISA-faz-alerta-importante-sobre-relogios-inteligentes-VEJA-300x155.png\" alt=\"\" width=\"300\" height=\"155\" srcset=\"https:\/\/www.guiafacilbrasil.com.br\/blog\/wp-content\/uploads\/2024\/03\/ANVISA-faz-alerta-importante-sobre-relogios-inteligentes-VEJA-300x155.png 300w, https:\/\/www.guiafacilbrasil.com.br\/blog\/wp-content\/uploads\/2024\/03\/ANVISA-faz-alerta-importante-sobre-relogios-inteligentes-VEJA.png 575w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/p>\n<p>Foto: Reprodu\u00e7\u00e3o.<\/p>\n<p>A\u00a0<strong>Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa)<\/strong>\u00a0emitiu uma nota t\u00e9cnica esclarecendo sua posi\u00e7\u00e3o em rela\u00e7\u00e3o ao uso de\u00a0<strong>smartwatches<\/strong>\u00a0(tamb\u00e9m conhecidos como rel\u00f3gios inteligentes) para a medi\u00e7\u00e3o de par\u00e2metros como\u00a0<strong>glicemia<\/strong>\u00a0(concentra\u00e7\u00e3o de a\u00e7\u00facar no sangue) e\u00a0<strong>oximetria<\/strong>\u00a0(satura\u00e7\u00e3o de oxig\u00eanio no sangue).<\/p>\n<p>De acordo com a\u00a0<strong>Nota T\u00e9cnica 12\/2024\/SEI\/GQUIP\/GGTPS\/DIRE3\/ANVISA<\/strong>, qualquer aparelho que realize medi\u00e7\u00f5es reconhecidas como de uso tipicamente m\u00e9dico deve ser\u00a0<strong>regularizado na Ag\u00eancia<\/strong>. Isso inclui medi\u00e7\u00f5es de glicemia, oximetria, press\u00e3o arterial, eletrocardiograma e notifica\u00e7\u00e3o de ritmo card\u00edaco irregular. Atualmente, existem\u00a0<strong>cinco softwares aprovados<\/strong>\u00a0na Anvisa para smartwatches, destinados \u00e0 medi\u00e7\u00e3o de press\u00e3o arterial, eletrocardiograma e notifica\u00e7\u00e3o de ritmo card\u00edaco irregular. No entanto,\u00a0<strong>n\u00e3o h\u00e1 dispositivos regularizados<\/strong>\u00a0para medi\u00e7\u00e3o n\u00e3o invasiva de glicose ou oximetria, devido \u00e0 falta de estudos com evid\u00eancias robustas sobre sua seguran\u00e7a e desempenho.<\/p>\n<p>A precis\u00e3o desses dispositivos \u00e9 crucial, pois erros podem resultar em doses inadequadas de insulina, com s\u00e9rias consequ\u00eancias imediatas ou de longo prazo. Portanto, a Anvisa alerta que os smartwatches n\u00e3o devem ser usados para controle glic\u00eamico. Caso sejam identificados an\u00fancios de rel\u00f3gios que aleguem a capacidade de realizar medi\u00e7\u00f5es n\u00e3o invasivas de glicemia, a Anvisa solicita que seja feita uma den\u00fancia. A venda de dispositivos m\u00e9dicos sem a devida regulariza\u00e7\u00e3o \u00e9 considerada uma infra\u00e7\u00e3o sanit\u00e1ria, sujeita a penalidades previstas pela Lei 6.437\/1977.<\/p>\n<p>Com informa\u00e7\u00f5es do Governo Federal.<\/p>\n<p>&nbsp;<\/p>\n<div>\n<div class=\"google-auto-placed\">\n<div id=\"aswift_3_host\" tabindex=\"0\" title=\"Advertisement\" aria-label=\"Advertisement\"><iframe loading=\"lazy\" id=\"aswift_3\" src=\"https:\/\/googleads.g.doubleclick.net\/pagead\/ads?gdpr=0&amp;client=ca-pub-1867025325766476&amp;output=html&amp;h=90&amp;adk=1701493149&amp;adf=616662408&amp;pi=t.aa~a.2924540085~rp.4&amp;w=848&amp;fwrn=1&amp;fwrnh=100&amp;lmt=1709813013&amp;rafmt=1&amp;to=qs&amp;pwprc=9922718127&amp;format=848x90&amp;url=https%3A%2F%2Fwww.guiafacilbrasil.com.br%2Fresultado%2Findex%3Fbuscar%3Dmedicos&amp;fwr=0&amp;fwrattr=false&amp;pra=3&amp;rpe=1&amp;resp_fmts=3&amp;wgl=1&amp;fa=40&amp;dt=1709813013356&amp;bpp=1&amp;bdt=1293&amp;idt=-M&amp;shv=r20240305&amp;mjsv=m202402290101&amp;ptt=9&amp;saldr=aa&amp;abxe=1&amp;cookie=ID%3D82a5025d674ba57f%3AT%3D1704806387%3ART%3D1709813007%3AS%3DALNI_MbYJCio4xXHPTEJqImOmFmvbCpOlg&amp;gpic=UID%3D00000db59b2d0105%3AT%3D1704806387%3ART%3D1709813007%3AS%3DALNI_MZShTHob1uAe5rzlxgQJyIVFrjNCw&amp;eo_id_str=ID%3Dfab46bc442db0ddb%3AT%3D1706618080%3ART%3D1709813007%3AS%3DAA-AfjZw_dD9ZCaMIrQOz880LATa&amp;prev_fmts=0x0%2C263x600%2C1005x124&amp;nras=3&amp;correlator=2961628183303&amp;frm=20&amp;pv=1&amp;ga_vid=1841769769.1704806387&amp;ga_sid=1709813013&amp;ga_hid=550791955&amp;ga_fc=1&amp;u_tz=-180&amp;u_his=4&amp;u_h=900&amp;u_w=1600&amp;u_ah=860&amp;u_aw=1600&amp;u_cd=24&amp;u_sd=1&amp;adx=222&amp;ady=1062&amp;biw=1583&amp;bih=775&amp;scr_x=0&amp;scr_y=682&amp;eid=44759876%2C44759927%2C44759842%2C31081613%2C44798934%2C95325753%2C95322181%2C95324161%2C95325784%2C95326431%2C95326936&amp;oid=2&amp;psts=AOrYGsmG2aXE3xx85cxBuRQSznx91Bw6iSzFqzcHvIiTaBGwcb7Of7G_epWSLocPsQdcvKIFelsxqw8wiZL6goAitBc842nn-RHagtCK0J2Vies9SIb_9g&amp;pvsid=3209576149461143&amp;tmod=445440623&amp;uas=0&amp;nvt=1&amp;ref=https%3A%2F%2Fwww.guiafacilbrasil.com.br%2Fresultado%2Findex%3Fbuscar%3Dmedcios&amp;fc=1920&amp;brdim=-8%2C-8%2C-8%2C-8%2C1600%2C0%2C1616%2C876%2C1600%2C775&amp;vis=1&amp;rsz=%7C%7Cs%7C&amp;abl=NS&amp;fu=128&amp;bc=31&amp;bz=1.01&amp;ifi=4&amp;uci=a!4&amp;fsb=1&amp;dtd=141\" name=\"aswift_3\" width=\"848\" height=\"90\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\" sandbox=\"allow-forms allow-popups allow-popups-to-escape-sandbox allow-same-origin allow-scripts allow-top-navigation-by-user-activation\" data-google-container-id=\"a!4\" data-load-complete=\"true\" data-google-query-id=\"CKfk3-qN4oQDFXuM7gEdHXAHLA\" data-mce-fragment=\"1\"><\/iframe><\/div>\n<div class=\"panel panel-default painel-estabeleciment \">\n<div class=\"row\">\u00a0\u00a0\u00a0\u00a0\u00a0 TerraBrasil \u2013\u00a0<a href=\"http:\/\/guiafacilbrasil.com.br\/blog\/\">\u00a0GuiaF\u00e1cilBrasil<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Foto: Reprodu\u00e7\u00e3o. A\u00a0Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa)\u00a0emitiu uma nota t\u00e9cnica esclarecendo sua posi\u00e7\u00e3o em rela\u00e7\u00e3o ao uso de\u00a0smartwatches\u00a0(tamb\u00e9m conhecidos como rel\u00f3gios inteligentes) para a medi\u00e7\u00e3o de par\u00e2metros como\u00a0glicemia\u00a0(concentra\u00e7\u00e3o de a\u00e7\u00facar no sangue) e\u00a0oximetria\u00a0(satura\u00e7\u00e3o de oxig\u00eanio no sangue). De acordo com a\u00a0Nota T\u00e9cnica 12\/2024\/SEI\/GQUIP\/GGTPS\/DIRE3\/ANVISA, qualquer aparelho que realize medi\u00e7\u00f5es reconhecidas como de uso tipicamente m\u00e9dico [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":20413,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[25],"tags":[],"_links":{"self":[{"href":"https:\/\/www.guiafacilbrasil.com.br\/blog\/wp-json\/wp\/v2\/posts\/20412"}],"collection":[{"href":"https:\/\/www.guiafacilbrasil.com.br\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.guiafacilbrasil.com.br\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.guiafacilbrasil.com.br\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.guiafacilbrasil.com.br\/blog\/wp-json\/wp\/v2\/comments?post=20412"}],"version-history":[{"count":1,"href":"https:\/\/www.guiafacilbrasil.com.br\/blog\/wp-json\/wp\/v2\/posts\/20412\/revisions"}],"predecessor-version":[{"id":20414,"href":"https:\/\/www.guiafacilbrasil.com.br\/blog\/wp-json\/wp\/v2\/posts\/20412\/revisions\/20414"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.guiafacilbrasil.com.br\/blog\/wp-json\/wp\/v2\/media\/20413"}],"wp:attachment":[{"href":"https:\/\/www.guiafacilbrasil.com.br\/blog\/wp-json\/wp\/v2\/media?parent=20412"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.guiafacilbrasil.com.br\/blog\/wp-json\/wp\/v2\/categories?post=20412"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.guiafacilbrasil.com.br\/blog\/wp-json\/wp\/v2\/tags?post=20412"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}