Masimo Announces FDA-Cleared "Over-The-Counter" Fingertip Pulse Oximeter
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Masimo (NASDAQ:MASI) announced FDA clearance for its MightySat Medical, the first and only FDA-cleared medical fingertip pulse oximeter available OTC without a prescription. This device, powered by Masimo SET pulse oximetry technology, offers accurate and reliable oxygen saturation and pulse rate measurements for consumers and is now available for purchase online and will soon be in retail and drug stores. The FDA clearance distinguishes MightySat Medical from other non-FDA cleared pulse oximeters, providing consumers and healthcare providers with a trusted option for home monitoring.
February 13, 2024 | 2:07 pm
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Masimo announced the FDA clearance of its MightySat Medical fingertip pulse oximeter, the first of its kind available OTC without a prescription. This product is expected to provide accurate and reliable measurements for consumers, leveraging the trusted Masimo SET pulse oximetry technology.
The FDA clearance of MightySat Medical positions Masimo (MASI) favorably in the consumer health market, distinguishing it from non-FDA cleared alternatives. This regulatory milestone, combined with the product's availability online and soon in retail, could significantly boost consumer trust and adoption, potentially increasing sales and positively impacting Masimo's stock in the short term. The reliance on Masimo's SET technology, proven in clinical settings, further strengthens the product's market position.
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