February 15, 2024 – Masimo introduced FDA clearance of MightySat^® Medical, making it the primary and solely FDA-approved medical fingertip pulse oximeter accessible over-the-counter with out a prescription. All different pulse oximeters accessible at drugstores and on-line and offered on to shoppers will not be FDA accredited and shouldn’t be used for medical functions; Lots of them have been reported to present incorrect readings. This approval offers shoppers with a medical machine with a pulse oximeter powered by Masimo SET^® pulse oximetry – the identical know-how that hospitals and clinics world wide depend on to observe greater than 200 million sufferers yearly and has been proven to haven’t any clinically vital distinction in accuracy or bias between light- and dark-skinned people. Starting February 13, the MightySat Medical Pulse Oximeter will be bought at masimo.com, and can quickly be accessible at retail and drugstores nationwide.

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