While rivals worked to build basic ECG functionality into smartwatches, AliveCor received FDA approval last year for a first-of-kind six-lead consumer ECG — the KardiaMobile 6L — that could be positioned at multiple sites on the user’s body, gathering additional heart rate data for broader measurements and greater diagnostic accuracy. Now, as the COVID-19 outbreak continues to worsen in the U.S., the FDA is permitting an expanded use of the device: Healthcare professionals can now use it to look for dangerously prolonged heartbeats caused by coronavirus medications.
Enabling an inexpensive, pocket-sized device to monitor COVID-19 patients could save lives during the pandemic, since multiple drugs are being rushed through testing to fight the virus. Although options such as hydroxychloroquine and azithromycin have been separately used for years to treat malaria and various bacterial infections, they may collectively prolong a patient’s “QT interval” — the time from the start of each heartbeat’s big Q wave spike to the end of its subsequent small T wave bump — and lead to drug-induced sudden cardiac death, a side effect even worse than the infection.
AliveCor notes that over 100 FDA-approved medications may prolong the QT interval, which is to say that something that appears to be effective at fighting COVID-19 could also silently kill patients. Moreover, hospitals are expecting an unprecedented influx of patients due to the coronavirus, surpassing their on-hand supplies of important equipment. Using KardiaMobile 6L to monitor patients for QT issues could free up both personnel and medical-grade ECG machines for other purposes.
KardiaMobile 6L “can play a key role in obtaining the patient’s QTc as a vital sign to help guide the rapid and safe use of these drugs,” said Mayo Clinic sudden death genomics lab director Michael J. Ackerman M.D., Ph.D. “In addition, the patient’s QTc can be obtained without exposing ECG technicians to affected patients, which helps to conserve personal protection equipment and thereby expand the capacity of our strained medical resources.”
The good news is that KardiaMobile 6L is available now, and health care professionals can manually calculate QT duration from six-lead ECG measurements patients take. On the other hand, its automated AI-driven monitoring solution doesn’t yet look for the issue, an omission the company says it will “soon” address with a “professional QTc monitoring service which would quickly provide the actual QTc value to health professionals.”
KardiaMobile 6L remains available for $149, a modest premium over the original $99 single-lead KardiaMobile. Unlike conventional ECG hardware, which has the footprint of a desk chair and is rolled by trained practitioners from room to room, KardiaMobiles can be attached to an Android or iOS phone using optional $15 phone clips and used by average consumers with a free AliveCor app. AliveCor is also working with Xiaomi’s Huami unit to incorporate heart rate-monitoring technologies into wearables with “entirely new ECG form factors” this year.