(RTTNews) - CytoSorbents (CTSO) announced that on June 18, 2025, it filed a request for supervisory review with the U.S. FDA of the De Novo Denial Letter issued on April 25, 2025 for DrugSorb-ATR Device. DrugSorb-ATR is designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting surgery within two days of stopping the antiplatelet drug Brilinta. The company determined that a supervisory review through the administrative appeals process was the best path to resolve the remaining deficiencies.
"The appeals process allows us to work more directly and effectively with senior FDA leadership connecting them with the company's leading external experts, including cardiac surgeons, who can provide the FDA with critical insight and expert consultation," said Phillip Chan, CEO of CytoSorbents.
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