{"id":15499,"date":"2021-05-31T09:08:38","date_gmt":"2021-05-31T14:08:38","guid":{"rendered":"https:\/\/saluddigital.com\/?p=15499"},"modified":"2025-10-21T12:39:30","modified_gmt":"2025-10-21T18:39:30","slug":"la-fda-y-la-aprobacion-de-dispositivos-que-utilizan-inteligencia-artificial","status":"publish","type":"post","link":"https:\/\/saluddigital.com\/en\/big-data\/la-fda-y-la-aprobacion-de-dispositivos-que-utilizan-inteligencia-artificial\/","title":{"rendered":"FDA and the approval of Artificial Intelligence-based devices"},"content":{"rendered":"
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The Food and Drug Administration (FDA), has taken actions related to the approval of Artificial Intelligence (AI)-based technologies with application in healthcare.<\/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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In January, the FDA published its Action Plan on Artificial Intelligence\/Machine Learning based software as Medical Devices. In addition, last year they created the Digital Health Center of Excellence that seeks to launch strategic initiatives that promote digital health technologies.<\/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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Recently, the FDA granted breakthrough status to an AI software designed for early detection of breast cancer and thyroid cancer. Through this AI-based system, it is possible to analyze breast and thyroid ultrasound images to support radiologists in determining whether a biopsy is necessary<\/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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Through this technology, it will be possible to prevent unnecessary biopsies of benign tissue and reduce costs for patients.<\/p>

On the other hand, the FDA also granted breakthrough status to an optical coherence tomography imaging system. This new system is using AI to help surgeons in their medical practice to determine whether, even after removing human tissue in an operation, cancer is still in the patient.<\/p>

Digital technologies approval<\/strong><\/p>

In addition to the approval of AI-based medical software, the FDA has also approved products related to digital technologies focused on therapeutic tools.<\/p>

For example, a digital therapy solution developed for the treatment of rheumatoid arthritis also received FDA status. This device works through a headset that sends electrical signals to modulate neurological pathways leading to a reduction in the pain of rheumatoid arthritis.<\/p>

Another example is the implantable micro sensor to facilitate remote monitoring of glaucoma patients, which received FDA breakthrough status.<\/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

FDA<\/strong><\/p>

https:\/\/www.fda.gov\/media\/145022\/download<\/a><\/p>

\u00a0<\/p>

MEDTECH DIVE<\/strong><\/p>

https:\/\/www.medtechdive.com\/news\/ai-digital-health-feature-in-latest-batch-of-fda-breakthrough-device-desig\/599584\/<\/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), ha realizado acciones relacionadas con la aprobaci\u00f3n de tecnolog\u00edas basadas en Inteligencia Artificial (IA) con aplicaci\u00f3n en salud. En enero la FDA, public\u00f3 su Plan de Acci\u00f3n sobre software basado en Inteligencia Artificial\/Aprendizaje autom\u00e1tico como Dispositivos M\u00e9dicos. Adem\u00e1s, el a\u00f1o pasado crearon el Centro de Excelencia de Salud Digital que busca el lanzamiento de iniciativas estrat\u00e9gicas que promueven las tecnolog\u00edas de salud digital. Recientemente la FDA otorg\u00f3 el estatus de avance a un software de IA dise\u00f1ado para la detecci\u00f3n temprana de c\u00e1ncer de mama y c\u00e1ncer de tiroides. A trav\u00e9s de este sistema basado en IA, es posible analizar im\u00e1genes de ultrasonido de mama y tiroides para brindar apoyo a radi\u00f3logos para determinar si es necesario realizar una biopsia. Mediante esta tecnolog\u00eda ser\u00e1 posible prevenir biopsias innecesarias de tejidos benignos y reducir costos para los pacientes. Por otra parte, tambi\u00e9n la FDA otorg\u00f3 el estatus a un sistema de im\u00e1genes de tomograf\u00eda de coherencia \u00f3ptica. Este nuevo sistema est\u00e1 utilizando la IA para ayudar a cirujanos en su ejercicio m\u00e9dico a determinar si aun despu\u00e9s de extirpar tejido humano en una operaci\u00f3n, el c\u00e1ncer sigue presente en el paciente. Aprobaci\u00f3n de tecnolog\u00edas digitales Adem\u00e1s de la aprobaci\u00f3n de softwares m\u00e9dicos basados en IA, la FDA tambi\u00e9n ha aprobado productos relacionados con las tecnolog\u00edas digitales enfocadas a herramientas terap\u00e9uticas. Por ejemplo, una soluci\u00f3n de terapia digital desarrollada para el tratamiento de artritis reumatoide tambi\u00e9n recibi\u00f3 estatus por parte de la FDA. Este dispositivo a trav\u00e9s de unos auriculares env\u00eda se\u00f1ales el\u00e9ctricas para modular las v\u00edas neurol\u00f3gicas lo que provoca la reducci\u00f3n de los dolores de la artritis reumatoide. Otro ejemplo es el del micro sensor implantable para facilitar la monitorizaci\u00f3n remota de pacientes con glaucoma, que recibi\u00f3 el estatus de avance por parte de la FDA. BIBLIOGRAF\u00cdA FDA https:\/\/www.fda.gov\/media\/145022\/download MEDTECH DIVE https:\/\/www.medtechdive.com\/news\/ai-digital-health-feature-in-latest-batch-of-fda-breakthrough-device-desig\/599584\/<\/p>","protected":false},"author":1,"featured_media":15500,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[156,3393],"tags":[145],"class_list":["post-15499","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-big-data","category-inteligencia-artificial-y-ciencia","tag-noticias"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/15499","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=15499"}],"version-history":[{"count":0,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/posts\/15499\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media\/15500"}],"wp:attachment":[{"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/media?parent=15499"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/categories?post=15499"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/saluddigital.com\/en\/wp-json\/wp\/v2\/tags?post=15499"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}