Most of the news that comes out of the Food and Drug Administration, or FDA, has to do with approving drugs, determining whether or not foods are safe, and, to some degree, keeping tabs on food-borne illness outbreaks. It might be shocking to learn, then, that they have recently moved into determining the safety and practicality of health-related algorithms. Learn about the process of receiving FDA approval for an algorithm, as well as learn about one company and the algorithms that the FDA has permitted them to market this year: the breakthrough year for healthcare algorithms.
For the most part, the FDA treats approving algorithms like it treats supporting other electronic health and fitness related items. Companies must file for De Novo approval, if an algorithm or product is their first foray into FDA approval, and can then move to file for 501(k) approval in following categories or with subsequent products.
An Apple Algorithm A Day Keeps Cardiovascular Disease At Bay
Many people around the world know Apple right off the bat: whether it’s the iPod, the iPad, the iPhone, or the iMac, nearly everyone owns one or knows someone who does. This year, Apple received approval from the FDA to market two different algorithms: both built into the functions of the Apple Watch. The first, built into the Series 4 Apple Watch, allows users to take 30-second ECG’s, which they can subsequently send to their doctors through the Apple Health Records app. The second, also built into the Series 4 model, can detect and alert the user to irregular heart rates that they may be experiencing. The company sought De Novo approval for the intermittent heartbeat function and found 501(k) support for the ECG feature.
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