LumiraDx Submits First 510(k) Application To The FDA For COVID Ultra Test
Portfolio Pulse from Happy Mohamed
LumiraDx Limited (NASDAQ:LMDX) has submitted its first 510(k) application to the U.S. Food and Drug Administration (FDA) for the clearance of its 5-minute COVID Ultra Test. This marks a significant milestone for LumiraDx's expansion into the United States. The company had earlier received various Emergency Use Authorizations (EUA) for its SARS-CoV-2 Ag tests during the pandemic. The LumiraDx SARS-CoV-2 Ag Ultra Test is already available in Europe and various international markets.
June 30, 2023 | 6:31 pm
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POSITIVE IMPACT
LumiraDx's submission of its first 510(k) application to the FDA for its COVID Ultra Test could potentially boost its expansion into the US market. This could have a positive impact on the company's stock in the short term.
The submission of the 510(k) application to the FDA is a significant step for LumiraDx as it seeks to expand its presence in the US market. If approved, this could lead to increased sales and revenue for the company, which could positively impact its stock price in the short term.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 100