OGT, a Sysmex Group company, has received premarket authorization under the FDA De Novo pathway, for its CytoCell KMT2A Breakapart FISH Probe Kit PDx. The authorization enables the use of the kit in the United States as a companion diagnostic for Revuforj in patients with KMT2A- rearranged acute leukemia.
De Novo Authorization is a regulatory pathway by the U.S. FDA for medical devices for which no substantially equivalent predicate exists in the U.S. market. Products granted De Novo authorization are classified as Class I or II after safety and effectiveness have been demonstrated and serve as predicates for future devices of the same type.
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Business News
May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.