Ventripoint Receives Market Clearance from US-FDA for Complete Heart Analysis System Using 2D Ultrasound
16 Mai 2018 - 2:38PM
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+™ 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.
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.
Neither the TSX Venture Exchange nor its
Regulation Services Provider (as that term is defined in policies
of the TSX Venture Exchange) accepts responsibility for the
adequacy or accuracy of this release.
For Further Information, Contact:
Dr. George Adams, CEO
T: (519) 803-6937
E: gadams@ventripoint.com
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