Tagged Content
Everything on the platform tagged with fda-clearance.

Mike Yang is the co-founder and CEO of LuxCreo, the company behind the world's first FDA Class II 510(k)-cleared direct-print clear aligner. A Harvard PhD and Wharton MBA, Yang spent a decade at Bloom Energy raising over $1B in green technology before pivoting to reinvent dentistry with light-based additive manufacturing. Under his leadership LuxCreo secured backing from Kleiner Perkins, achieved FDA clearance in 2022, launched in Europe in 2025, and is pushing same-day, in-clinic aligner production into mainstream dentistry.
Bob Schafer, PhD, is the CEO of Lumos Labs, the company behind Lumosity, the world's largest brain training platform with over 100 million users. A Stanford-trained neuroscientist with postdoctoral work at MIT, Schafer founded Prophecy Sciences (YC W13) before joining Lumos Labs via acquihire in 2015. He rose from Head of Research to Chief Science Officer to President of Lumosity DTx before being named CEO in May 2023. Under his leadership, Lumos Labs achieved FDA 510(k) clearance in December 2025 for LumosityRx (marketed as Prismira), the first prescription digital therapeutic for attention improvement in adults with ADHD — validated by a 500-participant randomized controlled trial.