{"id":55303,"date":"2023-03-29T14:03:04","date_gmt":"2023-03-29T12:03:04","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\/"},"modified":"2023-03-29T14:03:04","modified_gmt":"2023-03-29T12:03:04","slug":"fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\/","title":{"rendered":"FDA Grants Breakthrough Device Designation to Aural Analytics for Speech Analytics Software to Be Used in Treatment of ALS"},"content":{"rendered":"
\n

SCOTTSDALE, Ariz.–(BUSINESS WIRE)–Aural Analytics, Inc.<\/a>, a leader in clinical-grade speech analytics, today announced that its Speech Vitals – ALS technology has been granted designation as a Breakthrough Device by the US Food and Drug Administration (FDA). Speech Vitals – ALS is a software application used in the collection and analysis of speech recordings to assist neurologists in the monitoring of amyotrophic lateral sclerosis (ALS) in adults in both clinic and home environments.\n<\/p>\n

<\/a><\/p>\n

\nThe Breakthrough Device Designation is currently held by fewer than 800 devices, of which less than 140 are intended for neurological disorders and even fewer are used for ALS treatment. Medical devices receive breakthrough designation from the FDA when they provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the program is to provide patients and healthcare providers with timely access to groundbreaking technologies by expediting the approval process.\n<\/p>\n

\n\u201cAchieving breakthrough designation for Speech Vitals – ALS is explicit validation that the FDA sees the potential in the Speech Vitals platform to provide for more effective management of this devastating disease,\u201d said Jeremy Moore, Director of Quality Assurance & Regulatory Affairs at Aural Analytics. \u201cWe look forward to working closely with the agency to continue to develop our platform to achieve De Novo clearance to get it into the hands of the physicians and patients that need it the most.\u201d\n<\/p>\n

\nSpeech Vitals collects just a few minutes of speech samples from patients via app-based tasks that measure speaking rate, articulatory precision, phonatory duration and many other metrics. These metrics serve the purpose of assessing speech-motor conditions. Speech as a vital sign reduces the patient burden, as it is collected through a user-friendly app that can be deployed on any device in-clinic or at home. Speech Vitals is SDK-ready and can be embedded into provider and healthcare system applications, ensuring seamless integration into a clinician\u2019s everyday practice.\n<\/p>\n

\nAural Analytics intends to pursue additional indications using Speech Vitals – ALS, to include diagnosis. Once Speech Vitals achieves regulatory clearance, the technology will be applied to additional conditions that impact speech, such as Parkinson\u2019s Disease.\n<\/p>\n

\nAbout Aural Analytics, Inc.<\/span><\/b>\n<\/p>\n

\nAural Analytics is the industry\u2019s leading speech neuroscience company working with leaders in clinical research and the healthcare setting. Spun out from Arizona State University in 2015, the venture-backed company provides an easy to use Speech Vitals product platform that leverages structured speech elicitations to measure validated objective disease relevant information directly from patients in remote and clinical settings. For more information, please visit auralanalytics.com or follow Aural Analytics on Twitter<\/a>, LinkedIn<\/a>, and Facebook<\/a>.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nCaitlin Bates
\n
caitlin.bates@auralanalytics.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

SCOTTSDALE, Ariz.–(BUSINESS WIRE)–Aural Analytics, Inc., a leader in clinical-grade speech analytics, today announced that its Speech Vitals – ALS technology has been granted designation as a Breakthrough Device by the US Food and Drug Administration (FDA). Speech Vitals – ALS is a software application used in the collection and analysis of speech recordings to assist … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-55303","6":"format-standard","7":"category-industry"},"yoast_head":"\nFDA Grants Breakthrough Device Designation to Aural Analytics for Speech Analytics Software to Be Used in Treatment of ALS - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Grants Breakthrough Device Designation to Aural Analytics for Speech Analytics Software to Be Used in Treatment of ALS - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"SCOTTSDALE, Ariz.–(BUSINESS WIRE)–Aural Analytics, Inc., a leader in clinical-grade speech analytics, today announced that its Speech Vitals – ALS technology has been granted designation as a Breakthrough Device by the US Food and Drug Administration (FDA). Speech Vitals – ALS is a software application used in the collection and analysis of speech recordings to assist ... [Read more...]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pharma-trend.com\/en\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Trend\" \/>\n<meta property=\"article:published_time\" content=\"2023-03-29T12:03:04+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mms.businesswire.com\/media\/20230329005040\/en\/1748160\/21\/aural-logo-color_%281%29.jpg\" \/>\n<meta name=\"author\" content=\"Business Wire\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Business Wire\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\\\/\"},\"author\":{\"name\":\"Business Wire\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/person\\\/02d41342c7a74fa7f0032bb35ef0bb24\"},\"headline\":\"FDA Grants Breakthrough Device Designation to Aural Analytics for Speech Analytics Software to Be Used in Treatment of ALS\",\"datePublished\":\"2023-03-29T12:03:04+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\\\/\"},\"wordCount\":461,\"publisher\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20230329005040\\\/en\\\/1748160\\\/21\\\/aural-logo-color_%281%29.jpg\",\"articleSection\":[\"Industry\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\\\/\",\"url\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\\\/\",\"name\":\"FDA Grants Breakthrough Device Designation to Aural Analytics for Speech Analytics Software to Be Used in Treatment of ALS - Pharma Trend\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20230329005040\\\/en\\\/1748160\\\/21\\\/aural-logo-color_%281%29.jpg\",\"datePublished\":\"2023-03-29T12:03:04+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\\\/#primaryimage\",\"url\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20230329005040\\\/en\\\/1748160\\\/21\\\/aural-logo-color_%281%29.jpg\",\"contentUrl\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20230329005040\\\/en\\\/1748160\\\/21\\\/aural-logo-color_%281%29.jpg\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"FDA Grants Breakthrough Device Designation to Aural Analytics for Speech Analytics Software to Be Used in Treatment of ALS\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/\",\"name\":\"Pharma Trend\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#organization\",\"name\":\"Pharma Trend\",\"url\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"\",\"contentUrl\":\"\",\"caption\":\"Pharma Trend\"},\"image\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/person\\\/02d41342c7a74fa7f0032bb35ef0bb24\",\"name\":\"Business Wire\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"FDA Grants Breakthrough Device Designation to Aural Analytics for Speech Analytics Software to Be Used in Treatment of ALS - Pharma Trend","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/pharma-trend.com\/en\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\/","og_locale":"en_US","og_type":"article","og_title":"FDA Grants Breakthrough Device Designation to Aural Analytics for Speech Analytics Software to Be Used in Treatment of ALS - Pharma Trend","og_description":"SCOTTSDALE, Ariz.–(BUSINESS WIRE)–Aural Analytics, Inc., a leader in clinical-grade speech analytics, today announced that its Speech Vitals – ALS technology has been granted designation as a Breakthrough Device by the US Food and Drug Administration (FDA). Speech Vitals – ALS is a software application used in the collection and analysis of speech recordings to assist ... [Read more...]","og_url":"https:\/\/pharma-trend.com\/en\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\/","og_site_name":"Pharma Trend","article_published_time":"2023-03-29T12:03:04+00:00","og_image":[{"url":"https:\/\/mms.businesswire.com\/media\/20230329005040\/en\/1748160\/21\/aural-logo-color_%281%29.jpg","type":"","width":"","height":""}],"author":"Business Wire","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Business Wire","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/pharma-trend.com\/en\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\/#article","isPartOf":{"@id":"https:\/\/pharma-trend.com\/en\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\/"},"author":{"name":"Business Wire","@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/person\/02d41342c7a74fa7f0032bb35ef0bb24"},"headline":"FDA Grants Breakthrough Device Designation to Aural Analytics for Speech Analytics Software to Be Used in Treatment of ALS","datePublished":"2023-03-29T12:03:04+00:00","mainEntityOfPage":{"@id":"https:\/\/pharma-trend.com\/en\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\/"},"wordCount":461,"publisher":{"@id":"https:\/\/pharma-trend.com\/en\/#organization"},"image":{"@id":"https:\/\/pharma-trend.com\/en\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\/#primaryimage"},"thumbnailUrl":"https:\/\/mms.businesswire.com\/media\/20230329005040\/en\/1748160\/21\/aural-logo-color_%281%29.jpg","articleSection":["Industry"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/pharma-trend.com\/en\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\/","url":"https:\/\/pharma-trend.com\/en\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\/","name":"FDA Grants Breakthrough Device Designation to Aural Analytics for Speech Analytics Software to Be Used in Treatment of ALS - Pharma Trend","isPartOf":{"@id":"https:\/\/pharma-trend.com\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/pharma-trend.com\/en\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\/#primaryimage"},"image":{"@id":"https:\/\/pharma-trend.com\/en\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\/#primaryimage"},"thumbnailUrl":"https:\/\/mms.businesswire.com\/media\/20230329005040\/en\/1748160\/21\/aural-logo-color_%281%29.jpg","datePublished":"2023-03-29T12:03:04+00:00","breadcrumb":{"@id":"https:\/\/pharma-trend.com\/en\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/pharma-trend.com\/en\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/pharma-trend.com\/en\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\/#primaryimage","url":"https:\/\/mms.businesswire.com\/media\/20230329005040\/en\/1748160\/21\/aural-logo-color_%281%29.jpg","contentUrl":"https:\/\/mms.businesswire.com\/media\/20230329005040\/en\/1748160\/21\/aural-logo-color_%281%29.jpg"},{"@type":"BreadcrumbList","@id":"https:\/\/pharma-trend.com\/en\/fda-grants-breakthrough-device-designation-to-aural-analytics-for-speech-analytics-software-to-be-used-in-treatment-of-als\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/pharma-trend.com\/en\/"},{"@type":"ListItem","position":2,"name":"FDA Grants Breakthrough Device Designation to Aural Analytics for Speech Analytics Software to Be Used in Treatment of ALS"}]},{"@type":"WebSite","@id":"https:\/\/pharma-trend.com\/en\/#website","url":"https:\/\/pharma-trend.com\/en\/","name":"Pharma Trend","description":"","publisher":{"@id":"https:\/\/pharma-trend.com\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/pharma-trend.com\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/pharma-trend.com\/en\/#organization","name":"Pharma Trend","url":"https:\/\/pharma-trend.com\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/logo\/image\/","url":"","contentUrl":"","caption":"Pharma Trend"},"image":{"@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/person\/02d41342c7a74fa7f0032bb35ef0bb24","name":"Business Wire"}]}},"_links":{"self":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/posts\/55303","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/comments?post=55303"}],"version-history":[{"count":0,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/posts\/55303\/revisions"}],"wp:attachment":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/media?parent=55303"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/categories?post=55303"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/tags?post=55303"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}