Physicians have a new tool in their arsenal to help patients with COPD and other lung problems monitor their blood oxygen levels at home.
In February, the FDA approved MightySat Medical, the first over-the-counter medical fingertip pulse oximeter available without a prescription.
Masimo, the manufacturer of the MightySat, said the device was shown to have no clinically significant difference in accuracy or bias between light and dark-skinned individuals. It is now available through the company’s website and will soon be sold at retail and drug stores across the country.
The FDA said in a letter informing the company of its decision that it found the device to be “substantially equivalent” to a prescription product that Masimo began marketing in 2019.
Although other pulse oximeters are available for sale, the FDA issued a consumer advisory in 2021 advising consumers that the ones on the market at that time were not intended for medical purposes.
“Until now, consumers and even health care providers had no way of knowing what pulse oximeter they could trust to use at home,” said Joe Kiani, Masimo founder and CEO. “On the internet and even in drug stores, they are inundated with myriad products that are unreliable, with misleading advertisements about their abilities to provide accurate measurements of oxygen saturation and pulse rate. The clearance of MightySat Medical eliminates the confusion, placing an FDA-cleared, accurate and reliable SET pulse oximeter with technology that hospitals have been using for more than 25 years directly into their hands.”
