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Masimo wins first FDA clearance for OTC medical fingertip pulse oximeter

The company’s OTC device, which costs nearly $300, will compete with consumer pulse oximeters that are widely available but lack FDA clearance.

Masimo received Food and Drug Administration clearance for the first over-the-counter (OTC) medical fingertip pulse oximeter, the company said Tuesday.

The FDA, which noted the lack of cleared OTC devices in its 2022 pulse oximeter review, granted 510(k) clearance to Mightysat after finding it substantially equivalent to a prescription Masimo product that came to market in 2019.

Masimo’s OTC device, which costs $299.99, will compete with consumer pulse oximeters that are available at drug stores and online but lack FDA clearance. In 2021, the FDA advised consumers that all the OTC pulse oximeters then on the market were “not intended for medical purposes.”

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