iHealth Lab commercially launches fitness device

By: Aditi Pai | May 24, 2013        

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wireless sleep and activity trackerMountain View, California-based iHealth Lab, a subsidiary of Chinese medical device company Andon Health, announced a new device this week, the Wireless Activity and Sleep Tracker. As part of the announcement, iHealth also formed partnerships with two fitness tracking companies, MyFitnessPal and RunKeeper.

iHealth’s new fitness device comes as a wristband or belt clip, and unlike most other fitness tracking devices today, you don’t have to charge it. According to the company it has a three-year battery life. It syncs to an app that allows the user to set goals, measure activity in steps, calories or distance, and keep track of diet and sleep efficiency. It costs $60 and is commercially available in the US and Europe.

iHealth also announced another product that its billing as a health and fitness device, the Wireless Pulse Oximeter January. The device measures blood oxygen saturation and tracks pulse rate data. The device then transmits the information to a corresponding app that shows trends and stores information.

Other iHealth devices include blood pressure monitors designed to help those at risk of heart disease and digital weight scales that track body fat percentage and BMI in addition to weight. In December, iHealth partnered with EHR-maker Practice fusion and productivity app, Evernote.

Although there are many health-related tracking devices on the market, Withings matches iHealth Lab almost device for device. Unlike iHealth, Withings doesn’t have a Pule Oximeter and unlike Withings, iHealth doesn’t have a baby monitor. In January Withings announced an activity tracker, but has not yet put it on the market.

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Slideshow: 7 health, fitness crowdfunding projects

By: Jonah Comstock | May 24, 2013        

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Misfit Shine syncing on phone

The Misfit Shine raised $846,000 on Indiegogo in January.

Like the Misfit Shine before it, Scanadu proved this week that in digital health, the combination of a hip, hyped product and a crowdfunding platform can lead to impressive results. The company raised their goal of $100,000 in just two hours, and they’re now up to more than three times that.

Of course, not all digital and mobile health projects on Indiegogo or Kickstarter (which has quietly begun to go back on its former prohibition against health projects) achieve that level of success. Two months ago, we did a round-up of five mobile health projects on Indiegogo, and we’ve covered a number of crowdfunded companies in the meantime.

Four of the five companies in our March roundup surpassed their funding goals. The Amiigo fitness bracelet ended up raising $580,689, more than six times its $90,000 goal. The activity tracker surprised its backers by adding a previously unannounced sleep tracker shortly after the conclusion of the campaign. Breathometer, the smartphone breathalyzer, raised $138,377, more than five times its $25,000 goal. LifeBEAM’s SMART cycling helmet, an activity and heart rate tracker built into a bike helmet, raised $64,676 of its $50,000 goal. Silverline, the company refurbishing smartphones for seniors, just made their goal of $50,000, with a final total of $54,001.

The only company from our roundup that failed to meet its goal was MoodTune, a mobile game for treating depression, which raised only $1,955 out of a goal of $152,000. As did Lively, an eldercare monitoring system whose Kickstarter campaign we covered last month: they were only able to raise $15,177 of their $100,000 goal.

Other campaigns MobiHealthNews has written up recently are still ongoing, but promising. Goggle-based swim tracker Instabeat is already overfunded, with $43,823 raised out of a $35,000 goal and 25 days to go. The company’s stretch goal is $55,000. The Kinsa smart thermometer, which aims to create a realtime health map, is at $44,528 out of its $50,000 with 24 days left and the iPhone Placebo effect app is at $20,300 out of $50,000 with 31 days to go.

We’re always hearing about new mobile and digital health crowdfunding projects at MobiHealthNews. Read on for a slideshow of seven projects either currently seeking funds or recently concluded.

UPDATE: Make that eight! An astute commenter reminded us about HAPIFork, the app-connected fork that vibrates when the user eats too quickly. HAPIFork was met with some skepticism at CES in January and was mocked by Stephen Colbert shortly thereafter, but the crowd has definitely spoken: With a week to go, HAPILabs has raised $125,383 out of an original $100,000 goal.

In addition, a look at HAPILabs’ website suggests the fork is just the beginning: the company intends to introduce an activity tracker and a wristworn heart monitor.

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Busy week for FDA and mobile health, but no final guidelines yet

By: Brian Dolan | May 23, 2013        

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Brian Dolan, Editor, MobiHealthNewsSo far this past week was a busy one for those at the FDA’s device office focused on mobile medical app regulation. No, it didn’t release its final guidance document yet, even though Congress gave the agency a verbal lashing more than three months ago now. Still, the agency has had an unusually busy week.

Apart from the typical — like Rock Health alum Nephosity securing FDA 510(k) clearance for its iPad-based imaging app — the FDA likely read the news Tuesday morning that tricorder-like medical device maker Scanadu launched a crowdfunding campaign through IndieGoGo that will put a pre-FDA clearance device into the hands of consumers as a means to crowdtest the device and gather some of the needed data to secure that FDA clearance.

Scanadu’s CEO Walter DeBrouwer understands that this might be an unprecedented move, but he also believes that crowdsourcing platforms are going to push industry to rethink old processes. Scanadu’s Scout device isn’t likely to ship until at least March 2014 so it will take some time before we see how this one plays out, but after less than two hours of the crowdfunding campaign going live, Scanadu hit its goal of $100,000 raised.

The FDA hasn’t reacted to the Scanadu news, but it did finally get around to a urine analysis app that made headlines after being demo’d in a TED talk earlier this year. The FDA rarely makes a public show of proactively enforcing its mobile medical app regulations, but this week the agency made what was perhaps an unprecedented move by sending the app developer a letter informing it that its app might require 510(k) clearance or at least should be registered as a Class 1 device.

Biosense’s urinanalysis app uChek was using other medical devices — urine test strips — that were only cleared to be interpreted by the human eye, not a smartphone app’s camera or algorithm. EpsteinBecker’s Bradley Merrill Thompson, who is also the co-founder of the mHealth Regulatory Coalition and a longtime MobiHealthNews columnist, has been pointing to the uChek app for the past few months as an example of an app that the FDA should be enforcing its medical device guidelines against. Thompson even made mention of the app during his testimony at a congressional hearing in February.

One official announcement made by the FDA this past week was a posting in the Federal Register that declared “ingestible event markers” (IEMs), commonly called digital pills, to be Class II medical devices with some special controls. The new categorization is a result of the 510(k) clearance of Proteus Digital Health’s IEM paving the way with its clearance last summer.

While the post in the Federal Register is high profile, it’s really just a formality. Digital pills have been designated as a Class II device category since July 2012 thanks to Proteus, so the Federal Register posting is just a reminder that digital pills really arrived as a new regulated device category almost a year ago now. So, all you other digital pill developers, you have your predicate device.

Speaking of decisions that should have been made years ago… where are those final guidelines?

Digital health investments: ConsultingMD, Flexible Medical Systems

By: Aditi Pai | May 23, 2013        

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Over the course of the past few weeks, various digital health companies have raised funds. The roundup below includes investment news from companies that offer a range of digital health products and services, including online physician visits, non-invasive medical sensors, snail mail-powered remote monitoring devices, and portable blood test devices.

HomeBucket2PatchConsultingMD $10 million: Palo Alto, California-based ConsultingMD raised $10 million from Venrock Capital. The matching service takes a patient’s medical records, test results and pictures to find the appropriate doctor, according to a great Forbes article. ConsultingMD matches patients to top specialists in various fields to help them get a second opinion on diagnoses. The company plans to use the money to expand its network of physicians.

Flexible Medical Systems $301,785: Rockville, Maryland-based Flexible Medical Systems raised $301,785 from undisclosed investors according to an SEC filing. The company’s product, FlexMed, is a wearable, glucose monitoring sensor for people with diabetes that doesn’t draw blood. Instead, FlexMed measures glucose levels with tiny electrical signals to the patient’s skin.

Daktari Solutions $7 million: Cambridge, Massachusetts-based Daktari Solutions raised $7 million according to SEC filings. Daktari’s CD4 is a portable cell counting device that enables care providers to conduct blood tests in the field. Last year, Daktari raised $10 million from Merck Global Health Innovation Fund, Norwich Ventures and Partners Innovation Fund.

iRhythm $6 million: Last month, San Francisco-based iRhythm raised $16 million in funding led by Northwest Venture Partners according to a press release. The money will be used to fund development of new technology and commercial expansion. iRhythm’s Zio patch, which goes against the trend by having no connectivity embedded, monitors heart rate continuously for up to 14 days meant to catch arrhythmias in the patient.

Text4baby goes beyond the text, adds video

By: Jonah Comstock | May 23, 2013        

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Text4babyPhone

Voxiva, the company that developed the National Healthy Mothers Healthy Babies Coalition’s Text4baby free texting service for new mothers, announced a major update of Text4baby.

New Text4baby messages will include links to a mobile website containing “educational content and informational videos covering topics from exercise during pregnancy to car seat safety,” according to a release from the company. The American College of Obstetricians and Gynecologists (ACOG), the American Academy of Pediatrics (AAP), the March of Dimes, and the Centers for Disease Control and Prevention (CDC) have provided the content.

In addition, the texting component will be more interactive than before, allowing women to text “MORE” for more information, or “LIKE” to give Voxiva feedback on positive messages. They’ll also be able to use Text4baby to set reminders for their doctors’ appointments.

In other Text4baby news, a new independently conducted year-long study shows that Text4baby is effective in reaching its target population in San Diego, and in improving the health of pregnant women and new mothers. The service has had 540,000 mothers enroll since its launch.

The study was conducted by National Latino Research Center (NLRC) at California State University San Marcos and the University of California San Diego, with support from the Alliance Healthcare Foundation.

The study incorporates three phone surveys conducted over one year, one of which MobiHealthNews reported back in November 2011. The data produced by the complete study of 631 users of Text4baby are consistent with the findings returned by the first survey.

Users reported on whether messages from Text4baby caused them to take particular actions. For instance, 65 percent of women said Text4baby helped them remember an appointment or immunization, 74 percent said it informed them of medical warning signs they didn’t know, and 67 percent said they talked to their doctor about a topic from a Text4baby message.

Forty percent said they called a service number they learned about in a Text4baby message, including 50 percent of respondents without insurance.

The survey also collected demographic data about the San Diego users of Text4baby, to see whether the service was reaching its stated target demographic of low-income, minority women.

“The results from that really show that we’re reaching participants with a low household income,” Text4baby research manager Jessica Bushar told MobiHealthNews. “We also looked at ethnicity, age, parity, and household size.”

The average San Diego Text4baby user turned out to be 27.4 years old with a high school degree and an annual household income between $20,001 and $30,000. The average user has 1-2 children (including their current pregnancy) and 3 to 4 people living in their house total. Users were most likely to have insurance, and they gave the service an average satisfaction rating of 8.7 out of 10.

Additionally, 110 of the users in the study received text messages in Spanish. Of these, 95 percent reported that the Spanish in the messages was correct and the messages were clear and understandable.

Another recent efficacy study, conducted at George Washington University, found that Text4baby users were “nearly three times more likely to believe that they were prepared to be new mothers compared to those in the no exposure control group.” And Buschar told MobiHealthNews that two other studies are underway. One, conducted by Mathematica on behalf of the Department of Health and Human Services, will be complete by early 2014. Another is being undertaken by the Department of Defense and will be completed by the end of 2013 or the beginning of 2014.

How a physician’s smartphone camera might save lives

By: Jonah Comstock | May 22, 2013        

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A team of doctors at the University of Virginia medical center has developed an app to more easily, quickly, and efficiently transmit electrocardiogram tracings from heart attack patients to doctors, enabling doctors to diagnose a particular kind of heart attack that can benefit from immediate treatment.

UVA Medical Center

UVA Medical Center

A STEMI, or ST segment myocardial infarction, is a kind of heart attack, diagnosable from an EKG, in which the coronary artery is completely blocked off by a blood clot. It’s considered by many to be the most dangerous kind of heart attack, and one where the time saved by having doctors prepare for surgery ahead of time can be crucial.

The app, called STEMISend is meant to be used when someone is responding to a heart attack with a portable EKG machine. Normally, getting the data from the EKG machine to a physician can be a complicated proposition, Dr. David Burt told MobiHealthNews. Most of the existing commercial systems, where the EKG hooks up to a modem to send readings to a hospital computer, are expensive and time consuming. On the other hand, just snapping a photo with a mobile phone’s camera is not always high enough quality to be helpful, and can also take a long time.

STEMISend uses the phone camera but compresses the file size as much as possible while still maintaining a diagnostic-quality image.

“Our question was, could we design an app that would take a photo that’s diagnostic grade, cut it down in file size, and then test it and see how it works,” Burt said. “After we started to test all this we found out that actually this app works quite well. It transmits the photo clearly 94 percent of the time in 10 seconds or less.”

Burt and his team have been doing preliminary field testing on the app, taking pictures at various locations near UVA’s campus where heart attacks often occur, like local grocery stores. They tested the app more than 1,500 times via Sprint, AT&T and Verizon Wireless networks, with three or more bars of cellular service.

“In the future, we’re going to start testing it with zero, one, or two bars,” he said. “Shortly after this we’re going to test it head-to-head against commercial systems.”

The system can remain HIPAA compliant even though the pictures are sent through unsecure cellular networks in the same way that radio conversations with emergency response workers comply with HIPAA: by eliminating patient identifiers. The EKG images are sent without images or names of the patients.

Burt says the goal is to make this remain a low-cost option for hospitals that can’t afford to invest in expensive commercial systems:

“Our hope is that we can prove that it works, that it’s reliable, we can show how its performance stacks up against commercial systems, and then make it cheap as possible … so anybody who has a need for it can use it.”