CVR Medical Corp V.CVM.H

Alternate Symbol(s): CRRVF

Healthcare Biotechnology

CVR Medical Corp. is a medical technology organization. The Company is focused on the development and advancement of technology at work within the healthcare sector. The Company’s Carotid Stenotic Scan (CSS) is a diagnostic tool designed to detect and determine a level of carotid narrowing for the purpose of identifying patients at risk for Ischemic Stroke. The CSS provides a synergistic tool which complements other stroke screening technology, such as Duplex Doppler ultrasound (DUS), magnetic resonance angiography (MRA), and computed tomography angiography (CTA). The CSS is 100% non-invasive and does not require the use of harmful dyes. It offers its product to patients, payers, and healthcare providers. The CVR device uses only sound wave analysis to detect the presence of arterial stenosis.

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CVR Medical Corp

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Comment by Nastroon Apr 05, 2019 1:35pm

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Post# 29588743

RE:Approval Time

Mayo trial data is desirable though not necessary for the approval process. It’s primarily about marketing and credibility post approval rather than to get through the process itself. The FDA May possibly request additional trial data and the Mayo trials may be used then but that’s all. They would not have submitted in the first place if they didn’t have sufficient data. As I say 133 days is the average length of time it takes to approve a de novo application so it could quite conceivably be less than that. I don’t know whether it will just that it could.

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