Medical Device Network

FDA green lights Masimo’s fingertip pulse oximeter

The oximeter utilises Masimo’s Signal Extraction Technology (SET), which is used in several of the company’s wearables.

The US Food and Drug Administration (FDA) has granted clearance to health tech company Masimo’s MightySat Medical fingertip pulse oximeter, the first FDA-approved medical fingertip pulse oximeter that patients can buy without an over-the-counter prescription.

The oximeter uses Masimo’s Signal Extraction Technology (SET) pulse oximetry system. Clinicians utilise Masimo’s Measure-through Motion and Low Perfusion oxygen saturation (SpO₂) measurement technology for noninvasively identifying and continuously monitoring changes in patient status.

A pulse oximeter system is a small medical device used to measure oxygen saturation levels in the blood. Clipping onto a patient’s finger, it uses light to detect the amount of oxygen attached to haemoglobin in the blood, informing healthcare professionals about a patient’s respiratory function and oxygenation status.

According to a market model on GlobalData’s Medical Intelligence Center, the pulse oximeter market in the US is forecast to be worth $754m in 2030, and Masimo is one of the leading players.

The demand for pulse oximeters increased significantly during the Covid-19 pandemic, with the devices being used to monitor respiratory symptoms of patients with the SARS-COV-2 virus.

In the announcement accompanying the clearance, Masimo CEO Joe Kiani said: “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 over-the-counter medical pulse oximeter.”

In November 2023, Masimo teamed up with GE Healthcare to integrate its SET pulse oximetry technology with the 510(k)-approved Portrait Mobile wireless and wearable patient monitoring solution.

The company also received FDA clearance in December 2023 for its baby monitoring system, Stork, used for spot-checking and continuous SpO₂ and PR monitoring in neonates and infants during motion, no motion and low perfusion conditions.