Masimo announced that it has received U.S. FDA clearance for MightySat Medical, a medical fingertip pulse oximeter available over-the-counter (OTC), direct to consumers without a prescription. This device utilizes Masimo SET pulse oximetry technology and offers accurate readings for individuals of all skin tones, according to the company.
The MightySat Medical Pulse Oximeter can be purchased at masimo.com, and it will soon be available for purchase at retail and drug stores across the country.
“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,” says Joe Kiani, founder and CEO of Masimo.
“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. 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,” says Kiani.
In 2021, the FDA issued a safety communication clarifying that it does not review the accuracy of “health and wellness” pulse oximeters and highlighting the common limitations of both health and wellness and some prescription pulse oximeters—such as difficulty measuring accurately during patient motion, on patients with poor circulation (low perfusion), and on darker skin pigmentation.
MightySat Medical provides a direct-to-consumer option for a medical device with hospital-grade pulse oximetry technology, Masimo SET, whose performance has been reviewed and cleared by the FDA for medical use. MightySat Medical provides accurate and reliable oxygen saturation (SpO2) and pulse rate (PR) measurements on patients of all skin colors and patients with low perfusion.
Consumers with diagnosed breathing problems or lung diseases such as asthma, chronic obstructive pulmonary disease (COPD), lung cancer, flu, pneumonia, or COVID-19 depend on accurate assessment of their arterial blood oxygen saturation to share with their healthcare providers.
MightySat Medical with Masimo SET provides an FDA-cleared medical device with validated accuracy without the need for a prescription.
