Home Medizin FDA genehmigt rezeptfreies Pulsoximeter

FDA genehmigt rezeptfreies Pulsoximeter

von NFI Redaktion

According to a press release from the manufacturer Masimo, the MightySat Medical, an over-the-counter medical fingertip pulse oximeter, has received clearance from the US Food and Drug Administration (FDA) for use without a prescription.

The device is the first and currently the only medical fingertip pulse oximeter available directly to consumers without a prescription, and it features the same technology used in many hospitals, as stated by the company.

The use of pulse oximeters is crucial for patients with diagnosed respiratory problems or lung diseases such as asthma, chronic obstructive pulmonary disease, lung cancer, influenza, pneumonia, or COVID-19, to gather accurate data on arterial blood oxygen saturation that they can share with their healthcare providers, according to the company. Challenges in using pulse oximeters include measurement accuracy in patients in motion, measurement in patients with poor circulation, and measurement in patients with darker skin tones. The MightySat Medical aims to provide reliable measurements of oxygen saturation and pulse rate across all patient groups, the manufacturers stated in the press release.

Other over-the-counter pulse oximeters that are not FDA-approved could lead to confusion among patients about the accuracy of their measurements, according to the company.

„Healthcare providers can now also have confidence in referring their patients to MightySat Medical, knowing that it has indeed been approved by the FDA as an over-the-counter medical pulse oximeter,“ said Joe Kiani, founder and CEO of Masimo, in the press release.

MightySat Medical is suitable for individuals aged 18 and above who are well or poorly perfused at rest and is not intended as a diagnostic or screening tool for lung diseases, according to the press release. Treatment decisions based on the device’s data should only be made in consultation with a healthcare provider, the company added.

The FDA’s website offers guidance on using pulse oximeters at home with recommendations and limitations, as well as information on initiatives to ensure accurate and equitable pulse oximetry for all patients.

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