Masimo Announces ORi Granted De Novo As The First FDA-Cleared Noninvasive And Continuous Parameter To Provide Insight Into Hyperoxia Under Supplemental Oxygen
Portfolio Pulse from Benzinga Newsdesk
Masimo Corporation has announced that its ORi has been granted De Novo by the FDA, making it the first noninvasive and continuous parameter to provide insight into hyperoxia under supplemental oxygen. The product will be launched in the U.S. at ANESTHESIOLOGY 2023 this weekend.
October 13, 2023 | 12:04 pm
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POSITIVE IMPACT
Masimo's ORi has been granted De Novo by the FDA, a significant regulatory milestone. This could potentially boost the company's market position and stock value.
FDA clearance is a significant regulatory milestone for any medical device company. This clearance not only validates the safety and effectiveness of Masimo's ORi but also allows the company to market and sell the product in the U.S. This could potentially lead to increased revenues and a stronger market position, positively impacting the company's stock value.
CONFIDENCE 90
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RELEVANCE 100