Startups

iBeat has Dr. Oz, but what about FDA approval for the startup’s claims?

For now, Life Monitor is a direct-to-consumer product, not a medical device, though CEO Ryan Howard said iBeat will be seeking FDA clearance in 2017 in order to claim that the smartwatch can in fact detect cardiac arrest in advance.

By Neil Versel on October 11, 2016

iBeat

iBeat made some big news two weeks ago when Dr. Mehmet Oz invested in the health wearables startup and was named a special adviser to the company. It was a rare move for the TV personality.

“I’ve been reluctant to get involved in commercial endeavors,” Oz said Sept. 29 in a conference call with reporters. Indeed, this is only the second digital health company Oz is known to have invested in, after Jeff Arnold’s Sharecare.

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The controversial Oz, host of the “Dr. Oz Show” and a cardiothoraciac surgeon at Columbia University in New York, said he was drawn to iBeat’s Life Monitor and the hope that the device can detect warning signs for cardiac arrest. More importantly, he thought iBeat Life Monitor might be able to prevent sudden deaths.

“We’re optimistic we can move the needle here quite dramatically,” Oz said in that conference call.

He and iBeat founder/CEO Ryan Howard were careful not to claim that the smartwatch-like device can prevent cardiac arrest or heart attacks.

“Cardiac arrest” and “heart attack” often are used interchangeably in everyday conversation, but the terms are not synonymous. The American Heart Association describes the former as an “electrical problem” and the latter as a “circulation problem.”

There was a bit of a furor in the comments on MedCity News’ story and on social media after the iBeat news broke.

A story by Medgadget particularly set some people off because that piece initially made it sound like iBeat was making diagnostic claims it could not back up with scientific evidence. That, of course, is a big no-no in the eyes of the U.S. Food and Drug Administration. Medgadget has since corrected its story, Howard told MedCity News.

Cardiologist Dr. Dave Albert, founder and CMO of AliveCor, maker of a smartphone-based electrocardiogram attachment, was particularly peeved.

In an email last week, Albert said he has been asked about iBeat repeatedly since the Life Monitor came out and since Oz announced his involvement. “I just had to tell about ten people today that, ‘No, the watch cannot predict cardiac arrest or a heart attack,” and, “No, I have seen no data,'” Albert wrote.

Indeed, iBeat has not released data on what Life Monitor can do. In a video iBeat posted to YouTube last month, the startup said its watch “can save your life,” and “can detect for oncoming cardiac arrest.”

Still, Howard said his company is treading carefully. “We’re not diagnosing” any medical conditions, he said.

For now, Life Monitor is a direct-to-consumer product, not a medical device, though Howard said iBeat will be seeking FDA clearance in 2017 in order to claim that the smartwatch can in fact detect cardiac arrest in advance.

Howard said he is optimistic — but not positive — that the device eventually will be able to detect heart attacks as well, but that won’t be part of the company’s first FDA application. “We will likely be doing clinical trials so we can make broader claims, but we’re not doing so initially,” Howard said.

He did say that Life Monitor is more sophisticated than other popular wrist-worn gadgets on the market. “The sensor technology we’re using is well beyond what Fitbit or Apple Watch do,” Howard said.

Photo: iBeat