FDA hopes new disruptive wearables will lead to ‘ universal digital future in healthcare ’

The FDA is hopeful that devices like the new Apple (NSDQ:AAPL) Watch, which is designed to provide on-the-spot electrocardiogram tests and detect atrial fibrillation, will lead to a “reimagination of healthcare delivery,” according to a recent post from agency head Dr. Scott Gottlieb, but whether having that data will improve overall health has yet to be seen. In its unveiling of the new Apple Watch 4, the Cupertino, Calif.-based tech giant said it worked closely with the FDA to clear the device, which won de novo classification from the federal watchdog. Gottlieb confirmed that the agency “worked closely with the company as they developed and tested” the products, adding that the agency is hopeful that such devices could help users find treatment earlier and “truly empower them with more information about their health,” according to the post. “As a public health agency, we’re encouraged to see interest from developers in entering the digital health marketplace. And we want developers to know that the FDA stands ready to work with you to bring your safe, effective and innovative products to market. Our message today is clear—we want software developers to create new, innovative technologies that can help consumers take control of their health. As regulators, we will put patient safety at the forefront of what we do. And we will continue to work with developers to ensure their safe, effective and innovative products can enter the ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance AliveCor Apple Source Type: news