Photobiomodulation, also call LLLT, is a thing now, and FDA has issued draft guidance to deal with it. Not a lot of surprises here on the basic asks, but get ready for detailed expectations surrounding clearance. All this and our interview with Stephen Rapundalo of MichBio on the tradeshow floor of MEDICA in Dusseldorf Germany!

Chapters: Intro Local and National Events Seeing Red (Light)? FDA and Photobiomodulation Interview: Stephen Rapundalo - CEO - MichBio

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!

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MichBio: https://michbio.org/ MEDC: https://www.michiganbusiness.org/ FDA LLLT Guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/photobiomodulation-pbm-devices-premarket-notification-510k-submissions

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