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.
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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.
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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.
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By GlobalData“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.
