FDA clears Masimo’s OTC medical pulse oximeter, no perscription needed By Investing.com


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IRVINE, Calif. – Masimo (NASDAQ:) has announced the FDA clearance of its MightySat Medical, marking it as the first and only FDA-cleared medical fingertip pulse oximeter available over-the-counter (OTC) directly to consumers without a prescription.

MightySat Medical is designed to provide accurate and reliable measurements of oxygen saturation (SpO2) and pulse rate (PR) for individuals 18 years and older. It is intended for spot-checking these vital signs in both well and poorly perfused patients under no motion conditions. The device is not intended for the diagnosis or screening of lung disease, and treatment decisions using the device should only be made under the advice of a healthcare provider.

This FDA clearance addresses a significant concern in the market where consumers and healthcare providers were previously unsure about the reliability of pulse oximeters available without a prescription. Many non-FDA cleared devices have been reported to give erroneous measurements. The MightySat Medical offers a solution with hospital-grade technology, which is the same used to monitor over 200 million patients annually.

According to Peter Pronovost, MD, PhD, Chief Quality and Clinical Transformation Officer at University Hospitals, Cleveland, the accuracy of these devices is crucial as more care moves into the home. He emphasized that Masimo technology is trusted by medical professionals in hospitals.

The information for this article is based on a press release statement from Masimo.

InvestingPro Insights

Masimo (NASDAQ:MASI) has recently made headlines with the FDA clearance of its MightySat Medical, an over-the-counter medical fingertip pulse oximeter. As the company expands its consumer reach, investors are closely monitoring Masimo’s financial health and market performance. According to InvestingPro data, Masimo has a market capitalization of approximately $7.11 billion, with a high Price/Earnings (P/E) ratio of 80.89. This high P/E ratio suggests that investors are expecting high earnings growth in the future. Additionally, the company has shown a robust revenue growth of 21.17% over the last twelve months as of Q3 2023, indicating a strong market demand for its products.

InvestingPro Tips highlight several aspects of Masimo’s financial posture. Analysts have revised their earnings upwards for the upcoming period, reflecting optimism about the company’s future performance. Moreover, Masimo’s liquid assets exceed its short-term obligations, providing the company with a healthy liquidity position. However, it’s important to note that Masimo is trading at a high EBITDA valuation multiple, which may raise valuation concerns among some investors.

For those interested in a deeper dive into Masimo’s financials and market prospects, there are an additional 12 InvestingPro Tips available at InvestingPro. These tips provide valuable insights that can help investors make more informed decisions. To enhance your investing strategy, you can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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