Nonin Medical, a leading global manufacturer of wearable and noninvasive medical monitoring devices, has announced its first over-the-counter (OTC) FDA-cleared fingertip pulse oximeter – the TruO2 OTC. Dedicated to providing accurate readings on adults across all skin tones, the company says the device empowers patients and their healthcare professionals with accurate measurements, allowing them to make informed healthcare decisions.

The vast majority of pulse oximeters sold directly to consumers are classified as ‘health and wellness devices’ and are not required to meet the stringent requirements of the FDA for medical devices. This is because health and wellness products are only meant to promote a healthy lifestyle. They do not have any medical claims and are not intended to diagnose, treat, or prevent disease.

In fact, several low-cost devices have shown significant errors in estimating blood oxygen saturation. By contrast, OTC devices are classified as ‘medical devices’ and are regulated by the FDA, ensuring medical-grade technology is just as conveniently accessible to consumers as health and wellness products.