FDA approves Ventripoint complete heart analysis device
Ventripoint Diagnostics (TSXV:VPT) has received market clearance from the FDA to sell its VMS+ machine with a four-chamber heart analysis system in the U.S.
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,” Dr. George Adams, CEO, said in a statement.
“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,” he added.
There are more than 40 million cardiac ultrasound exams a year in the U.S.
Ventripoint said 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, which is employed worldwide as the first step in evaluating heart disease.
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, the company added.