CytoSorbents Corporation has announced an update on the U.S. FDA regulatory status of its DrugSorb-ATR device. Despite the FDA upholding the De Novo denial, the agency found no safety issues with the device and proposed a potential path forward for market authorization. The company is actively engaging with the FDA to address the outstanding issues and explore this proposed path. The DrugSorb-ATR, an FDA Breakthrough Device, aims to aid heart attack patients requiring urgent coronary artery bypass graft surgery who face the risk of perioperative bleeding due to blood thinners. CytoSorbents remains committed to bringing this technology to U.S. and Canadian markets.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. CytoSorbents Corporation published the original content used to generate this news brief via PR Newswire (Ref. ID: NY55311) on August 20, 2025, and is solely responsible for the information contained therein.