(MASI) Masimo Corporation Earns FDA New Product Approval
Masimo Corporation (MASI) recently received the U.S. Food and Drug Administration (FDA) approval for its new product, Masimo Rainbow SET Acoustic Monitoring. The new product enables noninvasive and continuous monitoring of human respiration rate (RRa). The data provided is accurate, easy-to-use, and thereby enhances patient compliance. With the approval, Masimo expects to launch the product in a limited market release in the U.S. in this month.
The new product enables earlier detection of respiratory compromise and patient distress. This is especially important for post-surgical patients receiving patient-controlled analgesia for pain management. It is seen that these patients often suffer from respiratory problems due to sedation, which can result in serious injury or even death. Masimo Rainbow SET Acoustic Monitoring also eliminates the lack of accuracy and patient compliance issues prevalent in tradition respiration rate monitoring devices.
We think that the enhanced features of the new product will allow it to be widely accepted by hospitals. This will in turn boost Masimo’s top line.
Masimo Corporation develops, manufactures and markets a family of non-invasive blood monitoring systems that consist of a monitor, circuit board and sensors. The systems are primarily used to monitor blood oxygen saturation levels and protect against hypoxemia and hyperoxemia. Hypoxemia, low blood-oxygen levels, can cause brain damage and death. Hyperoxemia, high-blood oxygen levels, can permanently damage the eyes and cause blindness.
Masimo is a leader in the pulse oximetry monitoring equipment market. The company’s closest competitors are Haemonetics Corporation (HAE) and Becton, Dickinson and Company (BDX). During fiscal 2008, the company gained five additional points of market share, taking it to 43.5%.
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