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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)

Therma Bright 为其人工智能驱动的数字咳嗽分析仪 (DCA) 准备了 FDA 513 (g) 审查文件
newsfile ·  2023/11/29 05:35

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解决方案通过Android和iOS移动应用程序以及用于监测患者咳嗽的临床医生仪表板提供了一组强大的用户和执业医师功能

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.

安大略省多伦多--(Newsfile Corp.,2023 年 11 月 29 日)——Therma Bright Inc.(多伦多证券交易所:THRM)(场外交易代码:TBRIF)(FSE:JNX)(“Therma” 或 “公司”)与其开发合作伙伴 AI4LYF,一家运营 ISO/IEC 的人工智能 (AI) 驱动型技术公司 27001和ISO:9001认证机构今天宣布,其人工智能驱动的数字咳嗽分析仪(DCA)已准备好接受向美国食品药品监督管理局提出的513(g)请求。

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)请求是Therma Bright从FDA获得有关其用作远程治疗监测(RTM)解决方案的声学人工智能数字咳嗽技术的分类和监管要求信息的一种手段。

"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."

“我们的数字咳嗽分析仪由 AI4LYF 在Therma Bright的独家许可下设计和开发,提供了一组当今市场上没有的独特功能,” Therma Bright首席执行官罗布·菲亚分享道,“我们不仅为下载Android和Apple iOS移动应用程序以捕获和管理咳嗽数据的患者和用户提供关键功能,而且临床医生仪表板是监测患者健康状况的强大工具。就拟议的RTM分类获得FDA同意的重要性在于,这将使公司能够立即向美国成千上万的医疗保健提供者启动其商业化计划。”

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认为,将其数字咳嗽分析仪提供给医疗保健提供商,通过可下载的移动应用程序为患者提供支持,将是对患者护理的极好支持。声学人工智能驱动的技术通过其移动应用程序提供许多患者/用户功能,并通过基于计算机的临床医生仪表板提供执业医生功能。

For user's, the Digital Cough Analyzer (DCA) mobile app features include:

对于用户而言,数字咳嗽分析仪(DCA)移动应用程序的功能包括:

  • 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.
  • 咳嗽检测: 基于 AI 的检测,可以区分咳嗽声音和非咳嗽声,以保护患者/用户的隐私。
  • 连续咳嗽计数器: 通过连续录制自动计数咳嗽次数,仅保存咳嗽声音以保护患者/用户的隐私。
  • 用户控件: 允许患者/用户安排咳嗽录制时间,并完全控制其数据-(i)可以将日期存储在自己的手机或云端,(ii)可以出于医疗和/或研究目的与医生共享所有或选定的数据,(iii)可以共享带有或不带有实际咳嗽音频的咳嗽模式,(iv)可以根据需要播放录制的咳嗽声音,保留或删除录音。
  • 报告: 用户可以生成和共享总结咳嗽模式的 PDF 报告文件,并在咳嗽记录中添加注释,例如,在服药或用餐后。

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.

对于执业者和研究人员而言,数字咳嗽分析仪的临床仪表板允许医疗保健专业人员查看患者的咳嗽数据,包括咳嗽记录,以更好地评估患者的健康状况。咳嗽数据和记录由患者共享,这使得HIPPA解决方案符合患者隐私的要求。

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《时代》杂志在 2023 年 4 月发表的一篇关于声学 AI 技术的文章所强调的那样,“除了记录咳嗽频率所能提供的初步用途外,最终目标是挖掘咳嗽数据,看看是否出现了区分流感咳嗽和 COVID-19 咳嗽或肺癌与过敏的不同特征。”研究表明,借助声学人工智能,使用咳嗽数据可能有助于诊断不同的健康问题或状况。Therma Bright和 AI4LYF 看到了由此带来的巨大好处,并通过他们的移动应用程序将这种功能交到公众手中。

Source: .

来源:。

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: .

关于 Therma Bright Inc
Therma Bright是各种前沿专有诊断和医疗设备技术的开发商和合作伙伴,致力于为消费者和医疗专业人员提供优质、创新的解决方案,以应对当今一些最重要的医疗和医疗保健挑战。Therma Bright Inc. 在(多伦多证券交易所股票代码:THRM)(OTCQB:TBRIF)(FSE:JNX)上市。访问:。

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.

关于 AI4LYF
AI4LYF 是一家创新的智能健康公司,其使命是通过深度智能改变生活。作为DCT的先驱,它还在研究基于人工智能的新型解决方案,这些解决方案有可能将 “反应性疾病护理” 转变为 “预测性、预防性、个性化医疗保健”,为所有人提供更充实、更长的寿命。

Therma Bright Inc.
Rob Fia, CEO
rfia@thermabright.com
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Therma Bright公司
首席执行官罗伯·菲亚
rfia@thermabright.com
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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.

前瞻性陈述
本新闻稿中的某些陈述构成 “前瞻性” 陈述。这些声明与未来事件有关,例如新闻稿中描述的DCA和相关技术的商业化。所有这些陈述都涉及大量已知和未知的风险、不确定性和其他因素,这些因素可能导致实际结果与此类前瞻性陈述所表达或暗示的结果有所不同。前瞻性陈述涉及重大风险和不确定性,不应将其视为未来业绩或业绩的保证,也不一定能准确表明是否会取得此类结果。由于多种因素和风险,实际结果可能与预期结果存在重大差异。尽管本新闻稿中包含的前瞻性陈述基于公司管理层认为截至本新闻稿发布之日的合理假设,但公司无法向投资者保证实际业绩将与这些前瞻性陈述一致。本新闻稿中包含的前瞻性陈述自本文发布之日起作出,除非适用的证券法规另有要求,否则公司不打算或没有义务更新或修改任何前瞻性陈述,无论是由于新信息、未来事件还是其他原因。

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