CVR Medical Corp.: Announces Completion of FDA Submission for CSS Device (CVM-TSX; CRRVF-OTCQB)

Posted by Karen Goldfarb

January 7, 2019 at 8:55 AM

CVR Medical Corp. announced today that it has completed a Food and Drug Administration De Novo Submission for its “Carotid Stenotic Scan (CSS)” device.  A De Novo Submission allows for a company to receive a “not substantially equivalent” risk-based evaluation for any legally marketed device for which there is no prior, comparable classification. 

The Company's CSS, which is a novel device that uses patented sound wave analysis technology to detect and measure carotid arterial stenosis, fits within the criteria of this FDA filing. Due to U.S. government shutdown, the submission will be reviewed by the FDA upon resumption of government activity.
 
CVR's FDA submission marks the culmination of the Company's many years of product development, design, trials, and organizational preparation, and is necessary for any new device entering the market.

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Learn move about CVR Medical by downloading our Executive Informational Overview (EIO), a 60-page report detailing the Company's business, product development, strategic relationships, market opportunities, competition, financials, risks, and more.

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Topics: cvr medical, medical technology company, carotid health, ischemic stroke, Carotid Stenotic Scan (CSS), stenosis, occlusion, stroke, duplex Doppler ultrasound (DUS), magnetic resonance angiography (MRA), computed tomography angiography (CTA), cerebral angiogram, Henry Ford Hospital, Thomas Jefferson University Hospital, ENTICES Study, Cleveland Clinic, Canon U.S.A., CVM-TSX, CRRVF-OTCQB, transient ischemic attack (TIA), atherosclerosis, Army Research Lab

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