This kind of technology has been technologically viable for decades. The fact that we’re only now seeing prototypes, not mass adoption, is an indictment of the legal framework around medical devices.
The FDA classifies these devices as high-risk because they might give a false result but completely ignores the guaranteed harm of not having them at all. It’s a system that punishes action and rewards delay.
The FDA classifies these devices as high-risk because they might give a false result but completely ignores the guaranteed harm of not having them at all. It’s a system that punishes action and rewards delay.