BRUSSELS/FRANKFURT/PARIS (dpa-AFX) - 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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