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A.WimalarathneO.LeeJ
Mechanotransduction for Muscle Protein Synthesis via Mechanically Activated Ion Channels
These applicants may see the De Novo pathway as a strategic opportunity to (1) define an entirely new category of medical devices, (2) influence the special controls required for the category, including the need for performance standards requiring clinical studies to ensure safety and effectiveness, (3) establish their device as the first predicate in the category (and initially the sole device with clearance in that particular product code), and (4) potentially amplifying the value of their core patents by tying performance standards to these underlying technological characteristics
Am J Physiol Heart circulatory Physiol (2006) 291(4):H1489506
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