Slideshow: 8 pillboxes that connect to your phone

By: Jonah Comstock | Mar 13, 2013        

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Vitality GlowCapMedication adherence is a huge problem, and it’s one that seems solvable. People fail to take the pills prescribed to them for many reasons, but one of the biggest is forgetfulness, especially among elderly patients who take a lot of medications and can easily become confused.

Pillboxes have always been the go-to technology to improve adherence, whether it’s a simple Monday-through-Friday organizer or a locked pillbox with a daily alarm. But mobile technology has added another component to the smart pillbox: connectivity. Now your pillbox doesn’t just remind you to take your pills; it can track whether you did take them and report that information back to a doctor or caregiver.

With Vitality GlowCaps going mainstream at CVS.com and new pillboxes debuting at CES in January and since then, the market for smart, connected pill bottles seems poised to explode.

“I think there will be many winners,” Josh Stein, CEO of smart pill bottle maker AdhereTech, told MobiHealthNews. “Adherence is such a big space that’s asking for technology to help it, and it’s a vastly complicated issue. There will certainly not be one winner. Many different solutions will win out. The best thing that could happen to us right now would be a large scale adaption of smart pillboxes and smart pill bottles, so that it becomes something people actually think about.”

Here’s seven companies using sensors and connectivity to help seniors remember to take their pills: Keep reading>>

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AliveCor competitor gets OTC clearance from FDA

By: Jonah Comstock | Mar 12, 2013        

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ECG Check

Cardiac Designs' FDA-cleared ECG Check, not yet commercially available.

A new ECG device for the iPhone 4s called ECG Check received over-the-counter clearance from the FDA last month. The device, which would be the first product from Park City, Utah-based Cardiac Designs, appears very similar to the AliveCor Heart Monitor, which is currently only cleared for prescription use. The device was submitted to the FDA July 23, 2012, one week before AliveCor’s July 30 submission.

Cardiac Designs is an apparent newcomer whose website has been registered since 2011 to N88 Consulting, a company run by Karim Marrouche. According to the FDA documents, Marrouche is the Managing Director of Cardiac Designs. The company’s website describes the ECG Check as coming soon, and says that it will be available for the iPhone 5 as well as the 4S, although the FDA filing mentions only the 4S. (AliveCor is presently only cleared for the iPhone 4 and 4S.) Marrouche was unable to field an interview before deadline.

It’s unclear how close the product is to actual market release. To secure 510(K) clearance, a company doesn’t necessarily need a fully developed product or any clinical data.

The filing describes the device as a “1-lead ECG Event Monitor specifically designed to operate with an iPhone 4S handset.” The device will record a preset amount of ECG activity, typically 30 seconds, and analyze the reading, returning a “stoplight” result: red, yellow, or green. The device automatically transmits results via Bluetooth to the phone, and from there can send it to the company or a care provider. The filing doesn’t mention HIPAA, but does give a nod to data security.

“The data can then be stored locally and/or transmitted to the ECG Check web center for analysis and assessment by qualified professionals,” the filing reads. “The ECG Check web center provides privacy and protection for user medical information and the ability to interact with Cardiac Designs, LLC technicians and engineers, as well as with their own caregivers.”

But although the device is cleared for over-the-counter use, the filing places significant restrictions on the functionality of the over-the-counter version.

“With a physician prescription, the user will be provided access to be able to trend their results and generate reports to provide to their physician or other caregivers,” the filing says. “…Users without a physician prescription will not be able to view the waveform.”

Neither ECG Check nor AliveCor is marketed as a diagnostic device, possibly for reasons related to FDA clearance. ECG Check’s filing documents list it specifically as non-diagnostic, while AliveCor says in the FAQ section of its website that AliveCor’s Heart Monitor does not provide a diagnosis at this time — a trained professional must interpret the results.

AliveCor’s Dr. Dave Albert told MobiHealthNews that he expects the over-the-counter version of AliveCor to be available in mid-2013. Albert said “part and parcel” of the FDA’s over-the-counter category restriction is that the device can only provide metrics, as opposed to raw data. This is a likely explanation for Cardiac Design’s “stoplight” functionality for non-prescribed users. Albert said that how AliveCor intends to deal with that restriction is “an AliveCor secret.”

UPDATE: Marrouche got in touch with MobiHealthNews via email and explained the product’s over-the-counter functionality.

“Upon purchase, the user will have access to immediate feedback of heart rate values and status (green/yellow/red),” he wrote. “Once a consultation can be done with a physician, the ECG and findings can be displayed for the user. This is the way the FDA’s OTC clearance allows currently, but future iterations will enhance functionality for the user’s benefit.”

Marrouche said the company is pursuing partnerships for the diagnostic interpretation of ECG Check’s data. He said the company has not locked in any partners. MobiHealthNews has learned that Marrouche has worked with eCardio in the past through his N88 Consulting company, but he told MobiHealthNews that ECG Check is not currently pursuing a relationship with eCardio.

Exclusive: Sleep coach company Zeo is shutting down

By: Brian Dolan | Mar 12, 2013        

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Zeo_iphone_new-1024x1024Since late last year it has been something of an open secret in some digital health circles that Newton, Massachusetts-based sleep monitoring and coaching company Zeo was winding down its operations and searching for a buyer. At least one investor was making veiled references to the company running out of money during various question-and-answer periods at the mHealth Summit in Washington DC last year. Zeo’s absence from the Consumer Electronics Show (CES) in Las Vegas this year — a must-attend for any company selling devices and companion services to consumers — was telling.

This past week the Better Business Bureau listed the company as being “out of business” and Zeo CEO Dave Dickinson participated in an online TEDMED event as the company’s “former CEO”. While there is no official announcement, no known buyer yet, it’s clear that Zeo as we knew it is now over.

Zeo’s original offering was a sleep monitor that included a wireless-enabled, sensor-equipped headband that users wore at night and a bedside display alarm clock that captured the data transmitted from the headband. When Zeo was first conceived by a group of Brown University students almost 10 years ago, the idea was for an alarm clock that could wake you up at just the right moment in your sleep cycle, during the right sleep stage, so that you would awake feeling refreshed. Zeo’s alarm clock had this functionality built right in when it launched in 2009. Before that launch, however, the startup discovered in early product tests that users wanted a device that could do more than just wake them up better, they wanted to know how well they were sleeping, too. Keep reading>>

Amerigroup Florida now covers Asthmapolis for asthma management

By: Brian Dolan | Mar 12, 2013        

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AsthmapolisA WellPoint health plan in Florida, called Amerigroup Florida, announced that it will offer Asthmapolis’ FDA-cleared mobile health device and service to its members with asthma.

Asthmapolis’ device is a sensor that sits atop (most) inhalers used by patients who have asthma or COPD. The sensor transmits data to a companion app on the user’s mobile phone every time the inhaler is used. The app can then track the time and location of each medication discharge, which can then be used to help patients and their care givers better understand their asthma triggers. Amerigroup Florida members who use Asthmapolis will receive ongoing education outreach through email, text, mobile apps, and phone support from a certified asthma educator. They also have the option to share the information they collect via the device with their healthcare provider or other care givers.

Amerigroup Florida will make the offering available in both English and Spanish. It says the program “is designed to help people stick with their daily preventive medications, reveal insights about their use of rescue medications and provide personalized feedback, targeted education and other tools that improve members’ ability to manage their own disease.”

Asthmapolis CEO and Co-founder David Van Sickle told MobiHealthNews in an email that the device and service will be made available to Amerigroup Florida members at no cost. If a member of that health plan is interested in using Asthmapolis but does not have a smartphone, Van Sickle said the companies will install a Qualcomm Life 2net hub in the person’s home. The Asthmapolis device will transmit data to the home-based hub, which will, in turn, send it to the cloud and to populate the companion apps and web-based services. Van Sickle also made clear that this is not a pilot, it’s a commercial deal for Asthmapolis.

Asthmapolis secured FDA clearance for its device and software last summer. Even before then, however, Asthmapolis had a deal in place with major healthcare system Dignity Health. In March 2012 Asthmapolis teamed up with Norton Healthcare, IBM, and the city of Louisville to help the area overcome its asthma issues.

Simplee unveils billing tool for care providers

By: Jonah Comstock | Mar 12, 2013        

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simpleeSimplee, makers of an online tool that helps patients deal with medical bills and claims, announced SimpleePAY, a new service offered directly to healthcare providers.

When Simplee announced $6 million in first round funding last May, MobiHealthNews described their existing offering, the Simplee medical wallet, as a Mint.com for healthcare, because it helps patients keep track of and make payments to different healthcare providers, as well as helping them avoid costly insurance mistakes.

SimpleePAY will extend those benefits to healthcare providers, with an online billing system. The platform includes an interactive digital bill that’s clearer and easier to understand than a paper bill, and will interactively incorporate an explanation of benefits. The system will give patients a range of payment options including mobile, installments, and discounts; pre-procedure cost estimates; and a loyalty program. The platform will be offered in three plans, with a scaling number of features: Select, Complete, and Ultimate.

“If you think about providers, consumer-driven healthcare is good for them as well,” co-founder and CEO Tomer Shoval told MobiHealthNews. “Years ago, they would get most of their revenue from government and from insurance. Now more of it [comes from] patients. If patients are confused or uncomfortable, it becomes a challenge for them.”

Shoval said that currently less than 5 percent of the $350 billion dollars spent on healthcare annually is paid online through digital payments. He said it costs providers an average of $10 per patient to make sure bills are paid via phone calls and snail mail. Simplee will enable more patients to pay their bills digitally. The platform also provides patient satisfaction surveys to help providers refine their payment processes.

“We do not believe in charging consumers, and we also believe that going D2C in healthcare is a challenge, and therefore our ability to go after the providers who have a direct relationship with the patients is important,” Shoval said.

The company is launching SimpleePAY with charter customer El Camino Hospital in Silicon Valley. (Clarification: An earlier version of the article referred to El Camino as a pilot. The hospital is a paying customer.) Other partners include Mutual of Omaha and health savings account provider ACS BNY Mellon.

FDA clears LifeScan’s long-awaited iPhone diabetes app

By: Brian Dolan | Mar 12, 2013        

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OneTouch Verio SyncAfter almost exactly four years, Johnson & Johnson company LifeScan has announced the launch of a Bluetooth-enabled glucose meter and companion iPhone app similar to the one the company showed off on-stage at an Apple World Wide Developer’s Conference in 2009 for the launch of iPhone 3.0. As MobiHealthNews exclusively reported following the Apple presentation, the LifeScan demonstration was really just a prototype at the time and no product launch was imminent. At the beginning of March the FDA cleared LifeScan’s OneTouch Reveal Diabetes Application with a 510(k). The company cited WellDoc’s DiabetesManager as its predicate device.

The new LifeScan app works with the OneTouch Verio Sync Meter and similar software is embedded in the OneTouch Verio IQ meter, according to the 510(k) summary document. The Verio Sync meter sends blood sugar test results directly to the app, which works with and Apple mobile devices running iOS 4+ operating systems, including iPhones, iPod touch devices, and iPads.

The app can store up to 2,500 blood glucose results and events and up to one year of results and events. The app synchronizes its time with the meter; makes it easy to tag meals and add notes; alerts the user of one or more patterns found in results once downloaded; enables user to manually enter data like results, carbs, activity, or medication; and allows user to share blood glucose results via text message or email.

LifeScan also tested the app with 168 trial users, including about two dozen children, at two different sites, according to its FDA clearance document. The studies were just to determine the app’s usability, and user feedback was overwhelmingly positive. (Read more in the PDF document over at FDA’s database here.)

At least one person from the original LifeScan team that helped put together that Apple presentation in 2009 is no longer with the company: Anita Mathew, the Lifescan executive demonstrating the meter at the Apple event, co-founded her own mobile diabetes startup, Glooko, in late 2011. Glooko developed a cable and companion app that connects a number of the most popular meters to Apple’s devices.

Of course, the most high profile iPhone-enabled glucose meter to have launched since the LifeScan demo in 2009, was Sanofi’s iBGStar, which AgaMatrix helped them develop. In December 2011 the FDA cleared the iBGStar, a tiny glucose meter that plugs directly into the the iPhone 3GS and iPhone 4+ devices’ connector port, and feeds data into an app on the device.