{"id":28144,"date":"2022-06-28T08:32:30","date_gmt":"2022-06-28T13:32:30","guid":{"rendered":"https:\/\/saluddigital.com\/?p=28144"},"modified":"2025-10-20T11:37:19","modified_gmt":"2025-10-20T17:37:19","slug":"software-de-ia-conversacional-es-designado-como-dispositivo-innovador-por-la-fda","status":"publish","type":"post","link":"https:\/\/saluddigital.com\/en\/noticias\/software-de-ia-conversacional-es-designado-como-dispositivo-innovador-por-la-fda\/","title":{"rendered":"Conversational AI Software Designated as a Breakthrough Device by the FDA"},"content":{"rendered":"
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The Food and Drug Administration (FDA) designated Wysa, Artificial Intelligence (AI) and mental health software, as an innovative device.<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Wysa is a company specialized in mental health support through conversational AI techniques. It recently received a groundbreaking designation from the FDA for its Digital Health and Mental Health services, specifically involving patients diagnosed with chronic musculoskeletal pain, depression, and anxiety.<\/p>

The FDA's Breakthrough Device Program is crucial to accelerating the development and approval of new medical devices and products that support the diagnosis and treatment of life-threatening diseases.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Wysa's bot has been trained to deliver cognitive behavioral therapy, which is delivered via smartphone. In addition, it has been shown to reduce symptoms of depression and anxiety, as well as improve physical function in patients with musculoskeletal conditions, as shown in a independent study<\/a> published in The Journal of Medical Internet Research<\/em> (JMIR).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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The study aimed to compare changes in participants' mental health over two months. Results showed that patients who received digital mental health interventions as part of orthopedic care achieved improvements in pain, physical function, and depression.<\/p>

\u201cWe are delighted to achieve this significant FDA designation and look forward to working closely with the Agency to continue the development of AI-based cognitive behavioral therapy,\u201d said Jo Aggarwal, CEO and co-founder of Wysa. In addition, he explained that the company's mission is to provide various mental health options and also to do so with a platform that is always available.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t BIBLIOGRAPHY<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t

BUSINESSWIRE<\/strong><\/p>

https:\/\/www.businesswire.com\/news\/home\/20220512005084\/en\/Wysa-Receives-FDA-Breakthrough-Device-Designation-for-AI-led-Mental-Health-Conversational-Agent<\/a><\/p>

fdanews<\/strong><\/p>

https:\/\/www.fdanews.com\/articles\/207902-wysas-ai-mental-health-software-designated-an-fda-breakthrough-device<\/a><\/p>

JMIR<\/strong><\/p>

https:\/\/formative.jmir.org\/2022\/5\/e36203<\/a><\/p>

https:\/\/humanfactors.jmir.org\/2022\/2\/e35668<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

La Administraci\u00f3n de Alimentos y Medicamentos (FDA), design\u00f3 a Wysa, software de Inteligencia Artificial (IA) y salud mental, como un dispositivo innovador. Wysa es una compa\u00f1\u00eda especializada en el apoyo en salud mental a trav\u00e9s de t\u00e9cnicas de IA conversacional.  Recientemente recibi\u00f3 una designaci\u00f3n innovadora por parte de la FDA en sus servicios de Salud Digital y salud mental, espec\u00edficamente el que involucra a pacientes con diagn\u00f3stico de dolor musculoesquel\u00e9tico cr\u00f3nico, depresi\u00f3n y ansiedad. El programa de dispositivos innovadores o Breakthrough Device de la FDA es crucial para acelerar el desarrollo y aprobaci\u00f3n de nuevos dispositivos y productos m\u00e9dicos que brindan apoyo en diagn\u00f3stico y tratamiento de enfermedades que atentan contra la vida de los pacientes. El bot de Wysa ha sido entrenado para ofrecer terapia cognitiva conductual, la cual se realiza a trav\u00e9s de un tel\u00e9fono inteligente. Adem\u00e1s, ha demostrado reducir s\u00edntomas de depresi\u00f3n y ansiedad, as\u00ed como el mejoramiento de funciones f\u00edsicas en pacientes con condiciones musculoesquel\u00e9ticas, seg\u00fan se muestra en un estudio independiente publicado en Journal of Medical Internet Research (JMIR). El estudio tuvo como objetivo comparar cambios en la salud mental de los participantes durante dos meses. Los resultados mostraron que los pacientes que recibieron intervenciones digitales en salud mental como parte del cuidado ortop\u00e9dica, lograron mejoras en los dolores, funciones f\u00edsicas y depresi\u00f3n. \u201cEstamos encantados de lograr esta designaci\u00f3n significativa de la FDA y esperamos trabajar estrechamente con la Agencia para continuar el desarrollo de la terapia cognitiva conductual basada en la IA\u201d, explic\u00f3, Jo Aggarwal, CEO y cofundador de Wysa. Adem\u00e1s, explic\u00f3 que la misi\u00f3n de la compa\u00f1\u00eda es proporcionar diversas opciones de salud mental y adem\u00e1s hacerlo con una plataforma que siempre est\u00e1 disponible. BIBLIOGRAF\u00cdA BUSINESSWIRE https:\/\/www.businesswire.com\/news\/home\/20220512005084\/en\/Wysa-Receives-FDA-Breakthrough-Device-Designation-for-AI-led-Mental-Health-Conversational-Agent FDANEWS https:\/\/www.fdanews.com\/articles\/207902-wysas-ai-mental-health-software-designated-an-fda-breakthrough-device JMIR https:\/\/formative.jmir.org\/2022\/5\/e36203 https:\/\/humanfactors.jmir.org\/2022\/2\/e35668<\/p>","protected":false},"author":1,"featured_media":28145,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3395,160],"tags":[145],"class_list":["post-28144","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-apps-moviles-e-internet-de-las-cosas","category-noticias","tag-noticias"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/28144","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/comments?post=28144"}],"version-history":[{"count":0,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/28144\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media\/28145"}],"wp:attachment":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media?parent=28144"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/categories?post=28144"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/tags?post=28144"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}