With new FDA clearances, ZIO is poised to finally add realtime, connected monitoring

By Jonah Comstock
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iRhythm Zio is in many ways a poster child for a connected health company. The company, which makes a peel-and-stick patch for mobile ECG recording, is one of the few wearable medical device companies to go public, and few digital technologies have as soundly improved on the status quo as Zio has on the Holter monitor, a long-term legacy monitoring technology.

There's only one problem with declaring iRhythm a connected health success story: It's not actually a connected device. As we have noted many times, the ZIO patch is wearable and sensor-driven, but it doesn't transmit those readings. It stores them and, after two weeks, the patient mails the patch to iRhythm. The company downloads the readings, analyzes them with a machine learning algorithm, and sends them to the user's physician. But evidence is mounting that real mobile connectivity is finally coming to the ZIO patch.

Correction: A previous version of this story said the patch was mailed to the physician, rather than to the company.

iRhythm received a clearance this month for the "Zio AT ECG Monitoring System" which the company confirmed to MobiHealthNews was for a new monitoring device – due out in the second half of this year – and mentioned on the company's recent earnings call. On that call, CEO Kevin King briefly discussed a new product with "timely transmission" in response to an analyst's query.

The analyst, Jason Mills, also said in a report for Canaccord Genuity that the next generation device would open up the mobile cardiac outpatient telemetry market to the company. 

"While the real-time segment of the A-ECG market represents an incremental addition to IRTC’s currently addressable [market], we see the real value of this offering to be implicit in iRhythm’s ability to become a full-line supplier for its customers, targeting both first- and second-line A-ECG monitoring (currently Zio targets only first-line), as well as expansion into new indications such as post-AF ablation, post-cardiac surgery and post- ischemic stroke," Mills wrote.

The summary text of the most recent clearance is not yet available, but there is a summary for a similarly-named 2015 clearance, "Zio SR ECG Monitoring Service". In that clearance, the SR stands for Skyrunner, an Internet Service Provider. So it is possible the AT in the new clearance could stand for AT&T. 

The 2015 clearance includes a patch with Bluetooth and a wireless hub to collect that data and send it to a doctor. The use case isn't for continuous transmission over the whole two weeks, but rather for the patient to be able to hold down a button to capture a 90-second snippet of the data the patch is collecting and send it immediately to a doctor. Segments longer than 90 seconds can be retrieved "upon explicit request from a clinician responsible for the patient’s healthcare". This would allow wearers of the patch to use it in a way similar to handheld ECGs such as AliveCor's Kardia product.

Smartphone connectivity isn't mentioned in the older clearance but seems very likely for a few reasons. One, Zio launched a patient-facing smartphone app in 2015, a few months after receiving this clearance, that gave patients a way to log symptoms, something which is mentioned in the clearance. Second, a 2014 patent filed by the company does reference both a smartphone and a smartwatch as likely computing devices that a connected version of the patch could transmit to.