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#cpap #fda #patientvoices #breakthroughdevices News Segments / How Patient Feedback is Revolutionizing the FDA's Feedback Loop / How to Qualify for FDA's Breakthrough Devices Program / Saying Goodbye to CPAP: Meet the Implantable Alternative for Sleep Apnea Chapters 0:00 - Intro 4:22 - FDA and Industry News 4:27 - PEC: How Patient Feedback is Revolutionizing the FDA's Feedback Loop 9:15 - The application of FDA's openness to patient feedback 16:16 - We need a breakthrough! How to qualify for FDA's Breakthrough Devices Program 24:51 - MTC Application of the breakthrough device 28:57 - Implantable CPAP? The new alternative to sleep apnea 33:32 - MTC Application of Inspire UAS 41:33 - Local and National Events 46:33 - Q&A and Outro Each week we bring you fresh FDA news and commentary, in-depth regulatory and development education, interviews with MedTech community members, and announcements of relevant events - all curated by your medical product development team at in2being, LLC. Listen at your leisure, or join us LIVE Fridays at 2-3 PM ET! MTC Playlist on YouTube: • Full Episodes MTC Playlist on Spotify: https://open.spotify.com/show/0I1MeKu... MTC Playlist on Apple Podcasts: https://podcasts.apple.com/us/podcast... MTC Playlist on Google Podcasts: https://podcasts.google.com/feed/aHR0... in2being: https://www.in2being.com MTC Landing Page: https://www.in2being.com/medtech-cros... MTC How Do I Get a 510(k) Series Playlist: • How Do I Get a 510(k) Series MTC De-Risking Medical Device Development Series Playlist: • De-Risking Medical Device Development Series The Power of Patient Voices: Transforming FDA's Feedback Loop https://www.fda.gov/patients/learn-ab... How to Qualify for FDA's Breakthrough Devices Program https://www.fda.gov/medical-devices/h... Saying Goodbye to CPAP: Meet the Implantable Alternative for Sleep Apnea https://www.fda.gov/medical-devices/r... Events: https://www.fda.gov/medical-devices/w... https://michbio.org/inspire_events/22... https://www.eventbrite.com/e/life-sci... https://www.projectmedtech.com/event-... https://resiconference.com/pitch-chal... https://michbio.org/lifesciencesshowc... https://renvcf.com/undemo/ https://themedtechconference.com/regi... CONTAINS NEITHER LEGAL NOR MEDICAL ADVICE