{"id":1487,"date":"2022-04-15T17:39:33","date_gmt":"2022-04-15T15:39:33","guid":{"rendered":"https:\/\/coalasolutions.com\/se\/?p=1487"},"modified":"2023-01-13T13:55:51","modified_gmt":"2023-01-13T12:55:51","slug":"coala-life-erhaller-fda-510k-godkannande-for-lungauskultation-och-ny-ekg-analysalgoritm","status":"publish","type":"post","link":"https:\/\/coalasolutions.com\/se\/coala-life-erhaller-fda-510k-godkannande-for-lungauskultation-och-ny-ekg-analysalgoritm\/","title":{"rendered":"Coala Life erh\u00e5ller FDA 510k godk\u00e4nnande f\u00f6r lungauskultation och ny EKG-analysalgoritm"},"content":{"rendered":"
\n

Coala Life meddelar idag att amerikanska Food & Drug Administration (FDA) godk\u00e4nt ytterligare indikationer och anv\u00e4ndningsomr\u00e5den f\u00f6r Coala Heart Monitor. Det nya FDA 510k-godk\u00e4nnandet m\u00f6jligg\u00f6r att systemet \u00e4ven kan anv\u00e4ndas f\u00f6r auskultation och \u00f6vervakning av patienters lungor p\u00e5 distans. Den nya funktionaliteten tillg\u00e4ngligg\u00f6rs omedelbart till existerande och nya anv\u00e4ndare.<\/strong><\/p>\n<\/div>\n

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Coala Heart Monitor erh\u00f6ll sitt f\u00f6rsta 510k-godk\u00e4nnande av FDA \u00e5r 2019. Indikationen inkluderade bland annat smartphone-baserad EKG p\u00e5 distans, automatisk detektion av f\u00f6rmaksflimmer och m\u00f6jlighet till auskultation av hj\u00e4rtat p\u00e5 distans.<\/p>\n

Den nya 510k-godk\u00e4nnandet g\u00f6r det nu m\u00f6jligt f\u00f6r v\u00e5rdgivare att anv\u00e4nda Coala Heart Monitor och dess integrerade stetoskop f\u00f6r att \u00e4ven lyssna och auskultera lungor p\u00e5 distans. Godk\u00e4nnandet breddar avsedd anv\u00e4ndning d\u00e4r systemet med sin molnbaserade v\u00e5rdportal kan anv\u00e4ndas av v\u00e5rdgivare f\u00f6r att hj\u00e4lpa att uppt\u00e4cka och f\u00f6lja olika typer av lung- och luftv\u00e4gssjukdomar.<\/p>\n

\u201dKring 15 miljoner amerikaner \u00e4r drabbade av kronisk lungsjukdom (KOL) och sjukdomen drabbar fr\u00e4mst kvinnor. V\u00e5rt nya FDA-godk\u00e4nnande ger v\u00e5rdgivare nu m\u00f6jlighet att nyttja v\u00e5rt system f\u00f6r att \u00f6vervaka dessa typer av kroniska sjuka patienter under l\u00e5ng tid i deras vardagsliv. F\u00f6rskrivningen av Coala Heart Monitor f\u00f6r dessa patienter omfattas av s\u00e5som tidigare av ers\u00e4ttningskoder f\u00f6r Remote Patient Monitoring (RPM)\u201d, kommenterar Dan Pitulia, VD f\u00f6r Coala Life.<\/p>\n

Den nya FDA-godk\u00e4nnandet omfattar \u00e4ven en f\u00f6rb\u00e4ttrad analysalgoritm f\u00f6r automatisk detektion av f\u00f6rmaksflimmer baserat p\u00e5 en kombination av RR-variabilitet och P-v\u00e5gsdetektion.<\/p>\n

Sedan v\u00e5ren 2020 har Coala Heart Monitor marknadsf\u00f6rts i USA f\u00f6r att lyssna p\u00e5 patienters lungor p\u00e5 distans med st\u00f6d av FDAs tillf\u00e4lliga regelverk 2020-D-1138-0001 som till\u00e4mpats under Covid-19. Nu erh\u00e5ller Coala Life ett permanent FDA-godk\u00e4nnande f\u00f6r denna indikation och den unika och nya respiratoriska \u00f6vervakningsl\u00f6sningen \u00e4r omedelbart tillg\u00e4nglig f\u00f6r befintliga och nya Coala-anv\u00e4ndare i USA.<\/p>\n<\/div>\n

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Om oss<\/strong><\/p>\n

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Coala Life \u00e4r ett svenskt medicintekniskt f\u00f6retag verksamt inom molnbaserad hj\u00e4rt- och lungdiagnostik. Bolaget har utvecklat och lanserat Coala Heart Monitor – en m\u00e5ngfaldigt prisbel\u00f6nad samt FDA- och CE-godk\u00e4nd produktplattform som m\u00f6jligg\u00f6r l\u00e5ngtids\u00f6vervakning, analys och algoritmbaserad diagnostik av hj\u00e4rta och auskultation av lungor i realtid och p\u00e5 distans. Coala Heart Monitor marknadsf\u00f6rs huvudsakligen mot v\u00e5rdgivare som f\u00f6rskriver produkt och tj\u00e4nst till patient f\u00f6r anv\u00e4ndning i vardagen och hemmilj\u00f6, utan behov att bes\u00f6ka n\u00e5gon v\u00e5rdenhet. Bolagets l\u00f6sningar bygger p\u00e5 m\u00e5ng\u00e5rig svensk forskning samt utveckling och skyddas av ett 30-tal patent. Huvudkontoret \u00e4r baserat i Uppsala och sedan 2019 \u00e4r det amerikanska dotterbolaget Coala Life Inc etablerat i Irvine, Kalifornien. Mer \u00e4n 10 000 patienter har anv\u00e4nt, diagnostiserats eller \u00e4r under l\u00e5ngtids\u00f6vervakning med Coala Heart Monitor. I Coala Care plattformen finns idag \u00f6ver 1 700 l\u00e4kare och sjuksk\u00f6terskor anslutna hos fler \u00e4n 500 v\u00e5rdgivare. F\u00f6r mer information se www.coalalife.com<\/a><\/strong><\/p>\n<\/div>\n

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F\u00f6r mer info, kontakta:<\/strong><\/p>\n

\n

Dan Pitulia, CEO Coala Life AB
\n+46 70 972 08 38,\u00a0dan.pitulia@coalasolutions.com<\/a><\/strong>
\nPhilip Siberg, Co-founder, Chief Strategy Officer and Head of IR
\n+46 70 790 67 34,\u00a0philip.siberg@coalasolutions.com<\/a><\/strong><\/p>\n

Certified Adviser
\nBolagets Certified Adviser \u00e4r Erik Penser Bank AB.
\nKontaktuppgifter: Erik Penser Bank AB, Box 7405, 103 91 Stockholm,
\ntel: +46 (0)8-463 80 00
\nemail:\u00a0certifiedadviser@penser.se<\/p>\n<\/div>\n

\n

Denna information \u00e4r s\u00e5dan information som Coala Life \u00e4r skyldigt att offentligg\u00f6ra enligt EU:s marknadsmissbruksf\u00f6rordning. Informationen l\u00e4mnades, genom ovanst\u00e5ende kontaktpersons f\u00f6rsorg, f\u00f6r offentligg\u00f6rande den 2022-04-15 18:30 CEST.<\/em><\/p>\n<\/div>\n

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Bifogade filer<\/strong><\/p>\n

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Coala Life erh\u00e5ller FDA 510k godk\u00e4nnande f\u00f6r lungauskultation och ny EKG-analysalgoritm<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Coala Life meddelar idag att amerikanska Food & Drug Administration (FDA) godk\u00e4nt ytterligare indikationer och anv\u00e4ndningsomr\u00e5den f\u00f6r Coala Heart Monitor. Det nya FDA 510k-godk\u00e4nnandet m\u00f6jligg\u00f6r att systemet \u00e4ven kan anv\u00e4ndas f\u00f6r auskultation och \u00f6vervakning av patienters lungor p\u00e5 distans. Den nya funktionaliteten tillg\u00e4ngligg\u00f6rs omedelbart till existerande och nya anv\u00e4ndare. Coala Heart Monitor erh\u00f6ll sitt f\u00f6rsta […]<\/p>\n","protected":false},"author":3,"featured_media":1645,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","_coblocks_attr":"","_coblocks_dimensions":"","_coblocks_responsive_height":"","_coblocks_accordion_ie_support":"","footnotes":""},"categories":[8],"tags":[64,63,61,65,62],"class_list":["post-1487","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nyheter","tag-algoritm","tag-ekg","tag-fda","tag-lungauskultation","tag-usa","department-privatkund","department-vardgivare"],"acf":[],"yoast_head":"\nCoala Life erh\u00e5ller FDA 510k godk\u00e4nnande f\u00f6r lungauskultation och ny EKG-analysalgoritm - Coala Solution - SE<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/coalasolutions.com\/se\/coala-life-erhaller-fda-510k-godkannande-for-lungauskultation-och-ny-ekg-analysalgoritm\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Coala Life erh\u00e5ller FDA 510k godk\u00e4nnande f\u00f6r lungauskultation och ny EKG-analysalgoritm - Coala Solution - SE\" \/>\n<meta property=\"og:description\" content=\"Coala Life meddelar idag att amerikanska Food & Drug Administration (FDA) godk\u00e4nt ytterligare indikationer och anv\u00e4ndningsomr\u00e5den f\u00f6r Coala Heart Monitor. 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Det nya FDA 510k-godk\u00e4nnandet m\u00f6jligg\u00f6r att systemet \u00e4ven kan anv\u00e4ndas f\u00f6r auskultation och \u00f6vervakning av patienters lungor p\u00e5 distans. Den nya funktionaliteten tillg\u00e4ngligg\u00f6rs omedelbart till existerande och nya anv\u00e4ndare. 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