FDA Clearance: The “PhysioGlove”- An innovative medical device for easy and diagnostically accurate 12 lead ECG recording by Commwell.
Heart attack is the number one killer in the western society. Early detection and intervention can prevent death and reduce damage to the heart. Diagnostic ECG should therefore be performed as early as possible to shorten hospital arrival time. Diagnostic ECG is also very important for overall patient assessment in the general practice.
Despite its universal importance, the ECG recording technique remained almost unchanged for over 100 years. It is still time consuming, requiring a highly trained and diligent performer. The lead wire disentanglement, skin preparation and correct placement of all 10 electrodes are challenging.
Now all this becomes unnecessary! The “PhysioGlove”, a groundbreaking product by Commwell Inc. turns ECG acquisition into a simple, quick and highly accurate act that can be performed even by the patients themselves.
The “PhysioGlove” diagnostic accuracy was tested and validated, amongst others, in two prestigious academic medical centers in Chicago. The "PhysioGlove" showed excellent diagnostic accuracy of about 95% in hundreds of patients suffering from a wide variety of heart problems. A preliminary report was presented at the 2008 American College of Cardiology scientific meetings.
The concept from the inventor eyes
The “PhysioGlove” inventor, Daniel David, MD, professor of cardiology says: “Three main objectives guided the development of the “PhysioGlove”: 1. Dispose of the ECG cables. 2. Ascertain the correct and reproducible electrode positioning. 3. Allow almost anybody, regardless of medical training to perform an accurate and reproducible ECG in about one minute.”
“Clearly, this is important for hospitals, clinics, EMS teams etc. However, I see a major need to enable the patients themselves to perform this and other important tests in their home, work-place, during travel etc.”
“Adding other parameters (NIBP, SaO2, Temp. etc) will soon transform the “PhysioGlove” into a highly versatile personal, remote medical management system. This will fulfill my long-lasting dream, to offer sophisticated medicine to the patients where they actually spend most of their lives namely, outside the hospital” says Dr. David.
The “PhysioGlove” is available now from Commwell, Inc.
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