FDA gives 2 startups OK for smartphone heart tracking

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SAN FRANCISCO — For a grow­ing U.S. aging pop­u­la­tion, track­ing heart health via a smart­phone can mean the dif­fer­ence be­tween life and death.

This week, two Sili­con Val­ley start­ups re­ceived a green-light from the U.S. Food and Drug Ad­min­is­tra­tion for mo­bile ap­pli­ca­tions that mon­i­tor pa­tients from home, a step for­ward for a na­scent dig­i­tal health in­dus­try that has pressed for more clar­ity from the agency on reg­u­la­tions.

AliveCor said it re­ceived the FDA’s ap­proval to de­tect se­ri­ous heart con­di­tions in elec­tro­car­dio­gram, or ECG, read­ings taken from a mo­bile de­vice. The com­pany says its newly ap­proved al­go­rithm can de­tect atrial fi­bril­la­tion, a form of car­diac ar­rhyth­mia that af­fects about one in four adults over age 40.

If its smart­phone-com­pat­i­ble heart-mon­i­tor de­vice de­tects an ab­nor­mal­ity, a phy­si­cian could in­ter­vene be­fore the pa­tient ex­pe­ri­ences a stroke or other life-threat­en­ing event. The de­vice fits most smart­phones and rests on a pa­tient's fin­ger or chest to record an ECG.

“Atrial fi­bril­la­tion is very hard to iden­tify,” said Euan Thom­son, AliveCor's chief ex­ec­u­tive. “A large group of peo­ple have it, but don’t know they have it.”

Mr. Thom­son said AliveCor can de­tect the con­di­tion and send the data to a car­di­ol­o­gist for re­view. The com­pany plans to in­cor­po­rate this al­go­rithm into its ap­pli­ca­tion and make it avail­able to con­sum­ers by Sep­tem­ber.

In ad­di­tion, startup Vi­tal Con­nect re­ceived ap­proval for a patch — the “HealthPatch MD” — that pa­tients can at­tach to one of three ar­eas on their chest and view their own bio­met­ric data on a mo­bile de­vice. Sen­sors em­bed­ded in the Band-aid-sized patch track heart rate, pulse vari­abil­ity, re­spi­ra­tory rate, skin tem­per­a­ture, steps, “fall” de­tec­tion and more.



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