
The company says that the regulatory nod makes MightySat Medical the first and only FDA-cleared medical fingertip pulse oximeter available over the counter (OTC), direct to consumers without a prescription.
Irvine, California-based Masimo powers its OTC pulse oximeter with its SET technology. Hospitals and clinics around the world utilize the SET technology. Just last week, the company announced that SET pulse oximetry technology performs consistently across a variety of skin pigmentations as well.
Masimo said in a news release that MightySat Medical offers accurate and reliable oxygen saturation (SpO2) and pulse rate (PR) measurements on patients of all skin colors and patients with low perfusion.
Beginning today, Masimo now offers the devices for purchase at its website. The company plans to make MightySat Medical pulse oximeters available for purchase at retail and drug stores in the U.S. soon.
During the early stages of the COVID-19 pandemic, pulse oximeters became a useful tool for obtaining certain metrics that may indicate infection. Consumers with breathing problems or lung diseases can now use them for an accurate assessment of their arterial blood oxygen saturation.
“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,” said 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.”
The FDA cleared the device for the spot-checking of functional SpO2 and pulse rate. Clearance covers individuals 18 years and older who are well or poorly perfused under no motion conditions. It’s not intended to diagnose or screen lung disease.