Therma Bright Prepares FDA 513(g) Review Document for Its AI-Driven Digital Cough Analyzer (DCA)
Therma Bright Prepares FDA 513(g) Review Document for Its AI-Driven Digital Cough Analyzer (DCA)
Company's DCA Solution Offers Robust Set of User and Medical Practitioner Features via an Android & iOS Mobile App and a Clinician Dashboard For Monitoring Patient's Cough
公司的DCA解決方案通過Android和iOS移動應用程序以及用於監測患者咳嗽的臨床醫生儀表板提供了一組強大的用戶和執業醫師功能
Toronto, Ontario--(Newsfile Corp. - November 29, 2023) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) (FSE: JNX) ("Therma" or the "Company"), developer and partner in a wide-range of leading-edge, proprietary diagnostic and medical device technologies, with its development partner AI4LYF, an artificial intelligence (AI) driven technology firm that operates an ISO/IEC 27001 and ISO: 9001 certified facility, announced today that its AI-driven Digital Cough Analyzer (DCA) is ready for a 513(g) request to the U.S. Food and Drug Administration.
安大略省多倫多--(Newsfile Corp.,2023 年 11 月 29 日)——Therma Bright Inc.(多倫多證券交易所:THRM)(場外交易代碼:TBRIF)(FSE:JNX)(“Therma” 或 “公司”)與其開發合作伙伴 AI4LYF,一家運營 ISO/IEC 的人工智能 (AI) 驅動型技術公司 27001和ISO:9001認證機構今天宣佈,其人工智能驅動的數字咳嗽分析儀(DCA)已準備好接受向美國食品藥品監督管理局提出的513(g)請求。
The formal 513(g) request is a means for Therma Bright to obtain information from the FDA regarding the classification and regulatory requirements for its acoustic AI digital cough technology to be used as a remote therapeutic monitoring (RTM) solution.
正式的513(g)請求是Therma Bright從FDA獲得有關其用作遠程治療監測(RTM)解決方案的聲學人工智能數字咳嗽技術的分類和監管要求信息的一種手段。
"Our Digital Cough Analyzer, designed and developed by AI4LYF under exclusive license to Therma Bright, offers a unique set of features not available in today's market," shared Rob Fia, CEO of Therma Bright "Not only do we offer key features for patients and users who download the Android and Apple iOS mobile apps to capture and manage their cough data, but the clinician dashboard is a powerful tool for medical practitioners and researchers who are monitoring the health of their patients. The importance of obtaining FDA consent on the proposed RTM classification is that it will allow the Company to immediately initiate its commercialization plans to thousands of health care providers across the United States."
“我們的數字咳嗽分析儀由 AI4LYF 在Therma Bright的獨家許可下設計和開發,提供了一組當今市場上沒有的獨特功能,” Therma Bright首席執行官羅布·菲亞分享道,“我們不僅爲下載Android和Apple iOS移動應用程序以捕獲和管理咳嗽數據的患者和用戶提供關鍵功能,而且臨床醫生儀表板是監測患者健康狀況的強大工具。就擬議的RTM分類獲得FDA同意的重要性在於,這將使公司能夠立即向美國成千上萬的醫療保健提供者啓動其商業化計劃。”
Therma Bright believes that making its Digital Cough Analyzer available to healthcare providers, to support their patients via a downloadable mobile app, will be an excellent support to a patient's care. The acoustic AI-driven technology offer numerous Patient/User features through its mobile app and Medical Practitioner features through a computer-based clinician dashboard.
Therma Bright認爲,將其數字咳嗽分析儀提供給醫療保健提供商,通過可下載的移動應用程序爲患者提供支持,將是對患者護理的極好支持。聲學人工智能驅動的技術通過其移動應用程序提供許多患者/用戶功能,並通過基於計算機的臨床醫生儀表板提供執業醫生功能。
For user's, the Digital Cough Analyzer (DCA) mobile app features include:
對於用戶而言,數字咳嗽分析儀(DCA)移動應用程序的功能包括:
- Cough Detection: AI-based detection that can distinguish cough sounds from non-cough sounds to preserve patient/user privacy.
- Continuous Cough Counter: Counts coughs automatically with a continuous recording, saving only cough sounds to protect patient/user privacy.
- User Controls: Allows patient/users to schedule cough recording times, as well as have complete control over their data - (i) can store date on their own mobile phone or the cloud, (ii) can share all or selected data with doctor for medical and/or research purposes, (iii) can share cough pattern with or without actual cough audio, (iv) can play back recorded cough sounds, retaining or deleting recordings, as desired.
- Reporting: Users can generate and share a PDF report file that summarizes cough patterns, as well as add notes to the cough recordings, e.g., after taking medicine or a meal.
- 咳嗽檢測: 基於 AI 的檢測,可以區分咳嗽聲音和非咳嗽聲,以保護患者/用戶的隱私。
- 連續咳嗽計數器: 通過連續錄製自動計數咳嗽次數,僅保存咳嗽聲音以保護患者/用戶的隱私。
- 用戶控件: 允許患者/用戶安排咳嗽錄製時間,並完全控制其數據-(i)可以將日期存儲在自己的手機或雲端,(ii)可以出於醫療和/或研究目的與醫生共享所有或選定的數據,(iii)可以共享帶有或不帶有實際咳嗽音頻的咳嗽模式,(iv)可以根據需要播放錄製的咳嗽聲音,保留或刪除錄音。
- 報告: 用戶可以生成和共享總結咳嗽模式的 PDF 報告文件,並在咳嗽記錄中添加註釋,例如,在服藥或用餐後。
For medical practitioners and researchers, the Digital Cough Analyzer's clinical dashboard allows healthcare professionals to review a patient's cough data, including the cough recording, to better assess the health of their patient. Cough data and recordings are shared by the patient, which makes the solution HIPPA compliant for patient privacy.
對於執業者和研究人員而言,數字咳嗽分析儀的臨床儀表板允許醫療保健專業人員查看患者的咳嗽數據,包括咳嗽記錄,以更好地評估患者的健康狀況。咳嗽數據和記錄由患者共享,這使得HIPPA解決方案符合患者隱私的要求。
As a Time Magazine article on acoustic AI technologies highlighted in April 2023, "Beyond the initial utility that chronicling the frequency of coughs can provide, the ultimate goal is to mine cough data to see if distinct signatures materialize that would distinguish, say, a flu's cough from a COVID-19 one, or lung cancer from allergies." With acoustic AI, research suggests that using cough data can possibly help diagnose different health issues or conditions. Therma Bright and AI4LYF see huge benefit for this, and putting this capability into the general public's hands via their mobile app.
正如《時代》雜誌在 2023 年 4 月發表的一篇關於聲學 AI 技術的文章所強調的那樣,“除了記錄咳嗽頻率所能提供的初步用途外,最終目標是挖掘咳嗽數據,看看是否出現了區分流感咳嗽和 COVID-19 咳嗽或肺癌與過敏的不同特徵。”研究表明,藉助聲學人工智能,使用咳嗽數據可能有助於診斷不同的健康問題或狀況。Therma Bright和 AI4LYF 看到了由此帶來的巨大好處,並通過他們的移動應用程序將這種功能交到公衆手中。
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About Therma Bright Inc.
Therma Bright is a developer and partner in a wide range of leading edge, proprietary diagnostic and medical device technologies focused on providing consumers and medical professionals with quality, innovative solutions that address some of today's most important medical and healthcare challenges. Therma Bright Inc. trades on the (TSXV: THRM) (OTCQB: TBRIF) (FSE: JNX). Visit: .
關於 Therma Bright Inc
Therma Bright是各種前沿專有診斷和醫療設備技術的開發商和合作夥伴,致力於爲消費者和醫療專業人員提供優質、創新的解決方案,以應對當今一些最重要的醫療和醫療保健挑戰。Therma Bright Inc. 在(多倫多證券交易所股票代碼:THRM)(OTCQB:TBRIF)(FSE:JNX)上市。訪問:。
About AI4LYF
AI4LYF is an innovative smart-health company with a mission to transform lives through deep intelligence. Having pioneered DCT, it is also working on AI based novel solutions that have potential to change the "Reactive Sick care" into "predictive, preventive, personalized health care" for fuller and longer lives for all.
關於 AI4LYF
AI4LYF 是一家創新的智能健康公司,其使命是通過深度智能改變生活。作爲DCT的先驅,它還在研究基於人工智能的新型解決方案,這些解決方案有可能將 “反應性疾病護理” 轉變爲 “預測性、預防性、個性化醫療保健”,爲所有人提供更充實、更長的壽命。
Therma Bright Inc.
Rob Fia, CEO
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FORWARD-LOOKING STATEMENTS
Certain statements in this news release constitute "forward-looking" statements. These statements relate to future events such as the commercialization of DCA and related technology as described in the news release. All such statements involve substantial known and unknown risks, uncertainties and other factors which may cause the actual results to vary from those expressed or implied by such forward-looking statements. Forward-looking statements involve significant risks and uncertainties, they should not be read as guarantees of future performance or results, and they will not necessarily be accurate indications of whether such results will be achieved. Actual results could differ materially from those anticipated due to several factors and risks. Although the forward-looking statements contained in this news release are based upon what management of the Company believes are reasonable assumptions on the date of this news release, the Company cannot assure investors that actual results will be consistent with these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof and the Company disclaims any intention or obligation to update or revise any forward-looking statements whether because of new information, future events or otherwise, except as required under applicable securities regulations.
前瞻性陳述
本新聞稿中的某些陳述構成 “前瞻性” 陳述。這些聲明與未來事件有關,例如新聞稿中描述的DCA和相關技術的商業化。所有這些陳述都涉及大量已知和未知的風險、不確定性和其他因素,這些因素可能導致實際結果與此類前瞻性陳述所表達或暗示的結果有所不同。前瞻性陳述涉及重大風險和不確定性,不應將其視爲未來業績或業績的保證,也不一定能準確表明是否會取得此類結果。由於多種因素和風險,實際結果可能與預期結果存在重大差異。儘管本新聞稿中包含的前瞻性陳述基於公司管理層認爲截至本新聞稿發佈之日的合理假設,但公司無法向投資者保證實際業績將與這些前瞻性陳述一致。本新聞稿中包含的前瞻性陳述自本文發佈之日起作出,除非適用的證券法規另有要求,否則公司不打算或沒有義務更新或修改任何前瞻性陳述,無論是由於新信息、未來事件還是其他原因。
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