From 510k to Class 1: A New Pathway for US Market Entry
Welcome back to Health Unlocked: The Power of Salutogenesis, where we explore cutting-edge ideas shaping the future of healthcare. In this episode, Jasen Petersen discusses how Ion Biotechnology is pivoting its US market entry strategy amidst shifting crypto and DeSci (Decentralized Science) market conditions. Instead of pursuing the costly and complex 510k regulatory pathway immediately, he reveals a new plan centered on launching the Ion Gel as a Class 1 medical device or even as a co...
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