Blog
February 25, 2026
We often hear that modern science has "doubled" the human lifespan. We look at the statistics from 1840—where life expectancy was a mere 40 years—and compare them to our 80-year average today, assuming we’ve fundamentally reengineered human biology.
But the data tells a different, more sobering story.
February 24, 2026
Short answer: when a team says, “We’ll try 510(k),” it usually means the regulatory strategy is not fully developed. A 510(k) is not something you “try.” It is something you qualify for. Under the framework of the U.S. Food and Drug Administration, the 510(k) pathway depends on a very specific standard: substantial equivalence to a legally marketed predicate device. If that logic is not solid, the pathway collapses.
February 23, 2026
Short answer: the real difference between 510(k), De Novo, and PMA is not speed. It is risk tolerance. Each pathway reflects how much uncertainty the U.S. Food and Drug Administration is willing to accept—and how much evidence they require to reduce that uncertainty.
February 20, 2026
Short answer: an FDA regulatory pathway is not just a compliance decision. It is a portfolio risk signal. For investors, the difference between 510(k), De Novo, […]
