Masimo wins first FDA clearance for OTC medical fingertip pulse oximeter

Dive Brief: Masimo received Food and Drug Administration clearance for the first over-the-counter (OTC) medical fingertip […]

Dive Brief:

  • Masimo received Food and Drug Administration clearance for the first over-the-counter (OTC) medical fingertip pulse oximeter, the company said Tuesday.
  • The FDA, which noted the lack of cleared OTC devices in its 2022 pulse oximeter review, granted 510(k) clearance to Mightysat after finding it substantially equivalent to a prescription Masimo product that came to market in 2019.
  • Masimo’s OTC device, which costs $299.99, will compete with consumer pulse oximeters that are available at drug stores and online but lack FDA clearance. In 2021, the FDA advised consumers that all the OTC pulse oximeters then on the market were “not intended for medical purposes.”

Dive Insight:

Pulse oximeters are widely available online, with prices starting at around $10. However, those devices are sold as general wellness or sporting/aviation products and lack FDA clearance.

“Until now, consumers and even healthcare providers had no way of knowing what pulse oximeter they could trust to use at home,” Masimo CEO Joe Kiani said in a statement. “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.”

Mightysat brings the Masimo SET pulse oximetry technology used in the company’s prescription devices to consumers. The device is almost identical to its prescription predicate. Masimo disabled the ability to track the respiration rate and Pleth Variability Index, a measure used in mechanically ventilated patients, and changed the labeling.

The OTC device also features an “updated calibration curve for improved performance, including across different skin pigments and genders.” Masimo ran bench tests using a low perfusion simulator to support the performance of the device “with the updated calibration curve under low perfusion conditions,” the firm said in its 510(k) filing.

The FDA has warned skin pigmentation and low perfusion can affect accuracy.

Mightysat is already for sale on Masimo’s website and “will soon be available for purchase at retail and drug stores across the country,” the company said. Masimo already sells an OTC pulse oximeter in Europe.

The clearance comes as Masimo works to expand its consumer-focused business. Masimo launched its Stork baby monitor in August. As of a third-quarter results conference call in November, the company was aiming to have the product on sale in 250 outlets by the end of the year and quadruple that figure in 2024. Masimo cited its 2022 acquisition of Sound United as an enabler of its work with retail outlets.

Original Article: (https://www.medtechdive.com/news/masmio-fda-otc-pulse-oximeter/707474/)