MightySat Medical will be available OTC, enabling it to be purchased by consumers without presenting a prescription
Masimo’s MightySat Medical fingertip pulse oximeter secures FDA clearance. (Credit: Business Wire)
American medical technology company Masimo has secured clearance from the US Food and Drug Administration (FDA) for the MightySat Medical fingertip pulse oximeter.
MightySat Medical will be available over-the-counter (OTC), enabling it to be purchased by consumers without presenting a prescription. Currently, it can be bought from the company’s website and it will soon hit the shelves of retail and drug stores in the US.
The company stated that FDA clearance now offers consumers access to a pulse oximeter medical device equipped with Masimo SET pulse oximetry. This technology is said to be relied upon by hospitals and clinics globally to monitor their patients, demonstrating no clinically significant variance in accuracy or bias between individuals with light and dark skin tones.
The Masimo MightySat Medical is designed for spot-checking the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It is indicated for use with individuals aged 18 and above, whether they are well or poorly perfused under motionless conditions.
However, MightySat Medical is not intended for diagnosing or screening lung disease, and treatment decisions should be made only under the guidance of a healthcare provider, said Masimo.
Masimo founder and CEO Joe Kiani said: “Until now, consumers and even healthcare providers had no way of knowing what pulse oximeter they could trust to use at home.
“On the internet and even in drug stores, they are inundated with a myriad of products that are unreliable, with misleading advertisements about their abilities to provide accurate measurements of oxygen saturation and pulse rate.
“This clearance of MightySat Medical for consumers eliminates the confusion, placing an FDA-cleared, accurate, reliable, and revolutionary SET pulse oximeter, with technology that hospitals have been using for more than 25 years, directly into their hands.”
In December 2023, Masimo’s Stork baby monitoring system obtained clearance from the FDA for the prescription use on healthy and sick babies aged zero-18 months.