AliveCor launched an expanded range of ECG determinations on its KardiaMobile devices. These new determinations are cleared by the FDA as of November 2020 and include Sinus Rhythm with Supraventricular Ectopy (SVE), Sinus Rhythm with Premature Ventricular Contractions (PVCs), and Sinus Rhythm with Wide QRS.
Why does it matter?
KardiaMobile devices already detect Atrial Fibrillation, Bradycardia, and Tachycardia — making six total heart conditions these devices can identify. Other FDA-cleared personal ECGs in the U.S. only detect one heart condition: Atrial Fibrillation. AliveCor’s new determinations will include a refined algorithm for detection of Atrial Fibrillation, improving sensitivity and specificity, and reducing the number of unclassified readings, false negatives, and false positives.
AliveCor’s Advanced Determinations provide the ability to identify intermittent rhythm abnormalities, which may otherwise be difficult to capture outside the doctor’s office or hospital. Users may experience increased confidence in whether a symptom they’re feeling in their heart is dangerous or relatively benign.
On the record
“This is a turning point in remote cardiac monitoring-no other personal ECG in the world can offer this range of determinations and this level of accuracy,” said Dr. Dave Albert, Chief Medical Officer at AliveCor.
“I believe that patients will find new comfort, clarity, and reassurance in AliveCor’s sophisticated algorithm and new determinations,” noted Daniel Frisch, M.D., an electrophysiologist of Thomas Jefferson University Hospitals. “And as we continue to shift to a remote care setting, the new insights help physicians, like myself, to collect and organize detailed patient information and improve care.”
Availability
AliveCor’s new Advanced Determinations are available to KardiaCare subscribers. KardiaCare membership includes a suite of exclusive features allowing members to take full advantage of their Kardia devices. In addition to accessing Advanced Determinations, members receive an evaluation of their ECG recording by a board-certified cardiologist every 90 days from the comfort of home. Other features include automatic ECG sharing with caregivers, a heart health report summarizing heart data over 30 days, and a care plan task list with reminders. Advanced Determinations have already begun rolling out to KardiaCare customers.