VPTDF - Ventripoint Receives Market Clearance from US-FDA for Complete Heart Analysis System using 2D Ultrasound
(via TheNewswire)
Toronto, Ontario / TheNewswire / May 15, 2018 - Ventripoint Diagnostics Ltd. ("Ventripoint" or the "Company") (TSXV:VPT) announces that it has received market clearance from the US Food and Drug Administration ("FDA") to sell its VMS+(TM) machine with the 4-chamber heart analysis system in the United States. The intended use is for the analysis of ejection fraction (function) and volumes of any chamber of the heart, where they are warranted or desired.
"The VMS+ is the first simple echocardiography system to be approved by the FDA for the 3D volumetric analysis of all four chambers of the heart using 2D ultrasound," stated Dr. George Adams, CEO of Ventripoint. "Now we can offer the VMS+ to American physicians so they can accurately and easily evaluate and monitor hearts in children and adults during a routine cardiology appointment."
The USA is the largest medical device market in the world with over 40 million cardiac ultrasound exams per year. 2D ultrasound is the modern stethoscope and is employed worldwide as the first step in evaluating heart disease.
The VMS+ product allows for the determination of heart function, expressed as ejection fraction or volumes of any of the four chambers of the heart using conventional 2D ultrasound. These measurements are increasingly recognized as critically important in monitoring the heart and predicting outcomes of patients. This applies to patients with heart failure, abnormal heart rhythms, congenital heart disease, pulmonary hypertension and hypertension. With the VMS+, it is now possible to obtain this valuable information quickly, easily and cost effectively.
For Further Information, Contact:
Dr. George Adams, CEO
T: (519) 803-6937
E: gadams@ventripoint.com
Forward Looking Statements:
The information in this release may contain certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company's current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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