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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...
About this update from Therma Bright Inc.
[{"type":"text","content":"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 CoughToronto, 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. 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. \"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.\" 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.For user's, the Digital Cough Analyzer (DCA) mobile app features include: Cough Detection: AI-based detection that can distinguish cough sounds from non-cough sounds to preserve patient/user p...