Medtech group VentriPoint Diagnostics Ltd (CVE:VPT) reported further progress on its flagship product, namely FDA approval to sell its VMS Plus machine with the four-chamber heart analysis system in the USA.
"The VMS Plus is the first simple echocardiography system to be approved by the FDA for the 3-D volumetric analysis of all four chambers of the heart using 2-D ultrasound," said Dr George Adams, chief executive officer of VentriPoint.
"Now we can offer the VMS Plus to American physicians so they can accurately and easily evaluate and monitor hearts in children and adults during a routine cardiology appointment."
The VMS+ is the first cost-effective and accurate artificial intelligence tool for measuring whole heart function using conventional ultrasound.
The USA is the largest medical device market in the world with over 40mln cardiac ultrasound exams per year.
Two-dimensional ultrasound is the modern stethoscope and is employed worldwide as the first step in evaluating heart disease.
Dr Adams added: "There is more and more evidence that volumes and function can predict which patients require more or less drugs and more careful monitoring and this what the VMS+ does easily and cost-effectively.
"Our mission to make it easier for every doctor worldwide to know what is actually happening with a heart without having to send everyone to an MRI has been advanced greatly with this approval. The rest of the world looks to the USA as a leader in cardiac care and so this will help us elsewhere as well."
Looking ahead, the company boss said: "We have sales and marketing plan for the USA and are now free to implement it.
"You are not allowed to even market a device in the USA without approval, but we have a number of leading centres who are aware of the VMS and have been asking when the VMS+ would be available. We can now actively contact them and solicit orders. We will be announcing these orders as they come in."
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