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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Business News
May 15, 2026 15:25 ET Apart from the confirmation of Kevin Warsh as the next Fed chair, the main news on the economics front this week included key price data from the U.S. and the first quarter economic growth figures from major economies. Both consumer prices and producer costs have started to reflect the effect of supply shocks due to the Middle East conflict. In Europe, GDP data was in focus, while inflation data from China dominated the news flow in Asia.