AliveCor has snagged a new 510(k) clearance from the FDA for its KardiaMobile 6L. This unlocks the rapid detection of abnormal QTc intervals, or delays in the heart’s ability to electrically recharge between beats.
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Many had expected AliveCor to be squashed by the launch of the first ECG enabled Apple Watch. But the California-based medical health company seems to be doing just fine. In fact immediately after the Series 4 launch, sales of its ECG monitors doubled. Probably as many people were not aware you could perform such measurements from the comfort of your home.
Unlike its earlier product range and the Series 4 Watch which have a single lead ECG, KardiaMobile 6L has a 6-lead system. In a care clinic ECG readers have 12 leads which are placed across a patient’s chest to pick up heart data. More leads mean a better view of your heart.
The FDA approved device delivers EKG leads I, II, II, aVL, aVR and aVF. All without messy gels and wires. To take a measurement rest your thumbs against the two electrodes with KardiaMobile 6L facing you. Then, touch the bottom electrode to the bare skin of your left knee or left ankle. It takes about 30 seconds to complete a reading.
The gizmo connects via Bluetooth to the accompanying smartphone app on your iPhone or Android smartphone. It can detect AFib, Bradycardia, Tachycardia and normal heart rhythm with more accuracy and detail than its competition.
KardiaMobile 6 – QT prolongation clearance
Now AliveCor has snagged another FDA certificate of approval. This potential extends the use of KardiaMobile 6L to monitor for monitoring cardiovascular side effects that can come with taking 100 medications.
QT prolongation is a measure of electrical abnormality in the familiar peaks and valleys on a ECG, i.e. it means a heart muscle needs longer the usual to recharge between heart beats. Disturbed QT prolongation effects around 1 in 2500 people and typically presents with syncope, seizures or sudden death.
With this new clearance, medical professionals will be able to use KardiaMobile 6L to capture a ECG which they can use to manually measure their patients’ QT interval. Patients can also measure this remotely by using InstantQT. This is a service that measures QT intervals rapidly through FDA-cleared software.
KardiaBand 6L is available on Amazon. You can still also purchase AliveCor’s more basic 1-lead monitor.
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