MobiHealthNews

FDA looks to De Novo pathway model as it unveils updates to Pre-Cert program

The FDA unveiled new updates on the ongoing Pre-Cert program including a Digital Health Innovation Action Plan, Pre-Cert Test Plan for 2019 and a Working Model. One of the big take aways from ...
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 ...
abc27

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 ...
MobiHealthNews

HIV self-test app connects users to care, FDA proposes De Novo update, and more digital health news briefs

De Novo rule proposal published for review. The FDA has published a new proposal for revisions to the De Novo regulatory pathway for devices without a predicate. The rule, which is currently available ...
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 ...
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FDA Releases Draft Guidance on De Novo Classification Process

FDA has issued draft guidance on the de novo device classification process, indicating that the agency will allow manufacturers to submit devices for de novo classification at the same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

ENDRA Life Sciences Provides Update on U.S. Regulatory Strategy for its TAEUS ® System

ANN ARBOR, Mich.--(BUSINESS WIRE)--ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS ®), announced today it will build on the content of its completed ...