Eko wins FDA clearance for heart murmur, Afib algorithm

Eko Devices has secured FDA clearance for an algorithm that allows its digital stethoscopes to detect heart murmurs and atrial fibrillation.
It’s the first FDA-cleared AI algorithm for the Berkeley, California-based company, which has been marketing its stethoscopes since 2015 but raised $20 million last year to further algorithm development.
“We’re very excited about what this means to patients,” Eko co-founder and CEO Connor Landgraf said in a phone interview. He said Eko is the first digital-stethoscope maker with its own FDA-cleared algorithm, though other digital stethoscopes incorporate AI.
Consumers and clinicians can pick from a growing array of tools to monitor heart health, including Apple Watches and Fitbits in addition to digital stethoscopes.
The FDA, meanwhile, cleared another device this month, Verily’s Study Watch, for clinical use in detecting irregular heart rhythms. The device tracks a range of biometric markers but is not available directly to consumers, a spokeswoman for Verily, a division of Google parent Alphabet, wrote in an email. Verily has been collaborating with iRhythm Technologies on clinical uses of the Study Watch, which could be incorporated into a remote monitoring regimen, the spokeswoman wrote.
Eko’s algorithm does not replace consumer devices. Rather, it is designed to improve the ability of clinicians in primary, urgent and emergency care settings to detect and diagnose irregular heartbeats, Landgraf said.
Patients whose smartwatches alert them to potential problems will still need a clinical follow-up, which could lead to a referral to a cardiologist, Landgraf said.
“The ability to do that quick screen upfront is really valuable,” Landgraf said, adding that it could benefit patients in rural areas who may not have easy access to specialists.
A point of distinction is that Eko captures the heart’s sound, while consumer-facing smartwatches generally track electrical signals. That allows the Eko algorithm to detect heart murmurs, which front-line clinicians can sometimes miss, said Dr. James Thomas, a cardiologist and director of the Center for Heart Valve Disease in the Bluhm Cardiovascular Institute at Northwestern Medicine in Chicago, in a phone interview.
“The sort of unique aspect of this is the murmur detection,” said Thomas, the principal investigator in a clinical trial incorporating Eko’s devices.
Thomas said he would like to see Northwestern clinicians using the Eko algorithm. “It does give you a very quick heads up that there may be something going on,” he said.
It may also rule out the need for follow-up echocardiograms, Thomas said. About 20% to 25% of the echocardiograms in his clinic turn out to be normal, he added. “There may be other reasons why the echo was performed, but if it was being done looking for valvular heart disease, then this will be a better way of refining the triage.”
Eko plans to distribute the algorithm initially as a software upgrade for existing users of its devices, the Core Stethoscope and the Duo, a combined stethoscope and electrocardiogram reader, Landgraf said.  The devices’ users number in the tens of thousands, including clinicians at Sutter Health and Mayo Clinic.
The company is working on other algorithms, Landgraf said. One – measuring low-ejection fraction and developed in partnership with Mayo Clinic – won FDA breakthrough status in December. Low-ejection fraction refers to the amount of blood being pumped out of the heart and is a signal of potential heart failure.

Original Article: (https://medcitynews.com/2020/01/eko-wins-fda-clearance-for-heart-murmur-afib-algorithm/)