Masimo W1 Medical Watch Gets FDA Clearance for OTC and Prescription Use
17 November 2023 - 11:13PM
Dow Jones News
By Stephen Nakrosis
Masimo on Friday said the Masimo W1 medical watch received
510(k) clearance from the U.S. Food and Drug Administration for
over-the-counter and prescription use
The Masimo W1 is "the first FDA-cleared watch to provide
continuous real-time oxygen saturation and pulse rate for OTC and
Rx use," the company said.
Data from the integrated Masimo MW-1 module is displayed in
real-time on the Masimo W1 watch touchscreen, the company said.
Section 510(k) of the Food, Drug and Cosmetic Act requires
manufacturers to give the FDA 90 days advance notice before they
can market a medical device.
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
November 17, 2023 16:58 ET (21:58 GMT)
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