Business Wire

The MIRA Surgical System Proceeds to FDA Substantive Review for Market Authorization Under the De Novo Classification Pathway

LINCOLN, Neb.--(BUSINESS WIRE)--Virtual Incision Corporation today announced its De Novo request was submitted and is under substantive review by the U.S. Food and Drug Administration (FDA). The ...
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MCRA Assists Noctrix Health with FDA Marketing Authorization via the De Novo Pathway for the NTX100 Tonic Motor Activation System

WASHINGTON, May 8, 2023 /PRNewswire/ -- MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory ...
Seeking Alpha

FDA Accepts DrugSorb-ATR De Novo Application To Reduce the Severity of CABG-Related Bleeding Due to Ticagrelor and Initiates Substantive Review

PRINCETON, N.J., Oct. 22, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (CTSO) (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac ...
Nasdaq

CytoSorbents announces FDA has accepted De Novo medical device application

CytoSorbents (CTSO) announced the U.S. Food and Drug Administration, FDA, has accepted its De Novo medical device application for DrugSorb-ATR and initiated substantive review. The goal of ...
MD&M East

FDA Releases Draft Guidance on De Novo Classification Process

FDA has issued draft guidance on the de novo device classification process, indicating that the agency will allow manufacturers to submit devices for de novo classification at the same time as they ...