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CytoSorbents submits Health Canada MDL application for DrugSorb ATR
The Fly

CytoSorbents submits Health Canada MDL application for DrugSorb ATR

CytoSorbents (CTSO) announced the submission of its DrugSorb ATR Medical Device License, MDL, application to Health Canada on November 1, 2024, concurrent with receipt of its Medical Device Single Audit Program, MDSAP, certification. DrugSorb-ATR, an investigational medical device, targets the ability to allow safe and timely coronary artery bypass graft, CANG, surgery in patients with acute coronary syndromes, ACS, on the blood thinning drug ticagrelor. The Canadian MDL application follows the Company’s DrugSorb-ATR U.S. Food and Drug Administration, FDA, De Novo filing which is now under substantive review.

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