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The MightySat Medical, an over-the-counter medical fingertip pulse oximeter, has received clearance from the US Food and Drug Administration (FDA) for use without a prescription, according to a press release from manufacturer Masimo.

The device is the first and currently the only medical fingertip pulse oximeter available directly to consumers without a prescription, and it includes the same technology used by many hospitals, according to the company.

Pulse oximeter use is important for patients with diagnosed breathing problems or lung diseases such as asthma, chronic obstructive pulmonary disease, lung cancer, flu, pneumonia, or COVID-19 to collect accurate data on arterial blood oxygen saturation that they can share with their healthcare providers, according to the company. However, challenges of pulse oximeter use include measuring accuracy when patients are moving, measuring patients with poor circulation, and measuring patients with darker skin types. The MightySat Medical is designed to provide reliable measures of oxygen saturation and pulse rate across all patient groups, the manufacturers wrote in the press release.

Other over-the-counter pulse oximeters that are not cleared by the FDA may create confusion among patients about the accuracy of their measurements, according to the company.

"Healthcare providers can also now be confident when referring their patients to get MightySat Medical knowing that it has actually been cleared by the FDA as an OTC medical pulse oximeter," said Joe Kiani, Masimo founder and CEO, in the press release.

MightySat Medical is indicated for individuals aged 18 years and older who are well or poorly perfused under no motion conditions and is not intended as a diagnostic or screening tool for lung disease, according to the release. Treatment decisions based on data from the device should be made only in consultation with a healthcare provider, the company said.

The FDA's website offers guidance related to at-home pulse oximeter use, with recommendations and limitations, as well as information on initiatives to ensure accurate and equitable pulse oximetry for all patients.