Regulatory Pathways for Cough Monitoring

Transcript

1. Regulatory Pathways for Cough Monitoring: FDA Validation Requirements Explained March 2025
2. ©2025 Strados Labs, Inc. Introduction ▪ ▪ ▪ 2
3. ©2025 Strados Labs, Inc. Semi-Automated Cough Counting Overview 3 ▪ ▪ ▪ ▪ • • ▪ •
4. ©2025 Strados Labs, Inc. Semi-Automated Cough Counting Overview Continued Three Steps 4 ▪ ▪ ▪ ▪ 1. Medical Device 2. Data Processing & Speech Obfuscation 3. Cough Counting
5. ©2025 Strados Labs, Inc. Validation of Medical Device for Data Collection ▪ ▪ • 5 2. Data Processing & Speech Obfuscation 3. Cough Counting 1. Medical Device Step 1
6. ©2025 Strados Labs, Inc. Steps 2 & 3 Validation of Data Processing and Cough Counting ▪ ▪ ▪ ▪ ▪ 6 1. Medical Device 2. Data Processing & Speech Obfuscation 3. Cough Counting
7. ©2025 Strados Labs, Inc. 7 Steps 2 & 3 Cont. Validation of Data Processing and Cough Counting 2. Data Processing & Speech Obfuscation 3. Cough Counting ▪ ▪
8. ©2025 Strados Labs, Inc. Will Validation of the Cough Counting Process Be Required In Your Study? ▪ ▪ ▪ ▪ 8
9. Contact our team to explore cough monitoring for your next research study. Strados Labs www.stradoslabs.com 1-800-STRADOS info@stradoslabs.com LA-00268 Cough Validation Overview March 2025 ® indicates a registered trademark of Strados Labs, Inc.
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