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, 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.

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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.”

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FDA clears Nephosity iPad app for diagnostic imaging

By: Neil Versel | May 22, 2013        

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Nephosity MobileCT

The pre-FDA clearance version of MobileCT

Nephosity, a San Francisco-based startup, has joined the swelling ranks of companies to receive Food and Drug Administration (FDA) 510(k) clearance for a mobile medical imaging app.

The FDA has approved Nephosity’s MobileCT Viewer iPad app for remote diagnostic viewing of CT, MRI and X-ray images when a fixed workstation is not readily available, Nephosity announced this week. The clearance is only good on the current, fourth generation of iPad and does not cover mammography.

Nephosity founder and CEO Michael Pan tells MobiHealthNews that the FDA granted clearance of the app only a “secondary” diagnostic resource because no current tablet can match the high-resolution display properties required for primary radiology workstations. Other makers of mobile imaging apps have received similar clearances; MIM Software is marketing its MobileMIM product as a backup to rather than a substitute for fixed imaging stations.

Though Nephosity MobileCT Viewer has the FDA stamp of approval, the cleared version is not yet available in the iTunes App Store because the company is refining some features. “We’re trying to release a new version that works well with Jack Imaging,” a Web-based viewing platform from Nephosity that is in private beta, Pan says. Users will be able to log in through either service and see the same set of images without having to import files twice, he explains.

In addition, the company has to wait for Apple to review and accept the update before the FDA-cleared app appears in the AppStore. “The Apple turnaround time is so long,” Pan says.

With the iPad clearance in hand, Nephosity is moving forward with plans to seek FDA authorization on other devices and to integrate its technology with electronic health records (EHRs).

One of the six “menu” items in Stage 2 of the Meaningful Use incentive program is for providers to make at least 10 percent of medical images viewable directly through the EHR; hospitals and physicians must meet three of the six menu objectives. Pan says his company, which was a member of mobile health accelerator Rock Health’s spring 2012 class of startups, is discussing partnerships with several EHR vendors and medical imaging centers.

Nephosity also will be looking for FDA clearance of Jack Imaging, which runs in HTML5, through Web browsers and on some popular Android tablets, but Pan does not have a timetable for that. Pan says the company is waiting for the next release of the iPad Mini, rumored to have the high-resolution Retina display, before Nephosity seeks FDA clearance on the smaller Apple tablet.

Pan is a former DreamWorks Animation image-rendering pro with credits including “Shrek the Third,” “Kung Fu Panda” and “How to Train Your Dragon.”

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Quarter of nurses have a work smartphone

By: Jonah Comstock | May 22, 2013        

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nursing studiesDespite 75 percent owning personal smartphones, only a quarter of nurses at acute care hospitals have a smartphone available to support their nursing work, according to a survey by Voalte, which markets a smartphone-based secure hospital communication system, and American Nurse Today, the official journal of the American Nurses Association.

Voalte told MobiHealthNews that American Nurse Today helped conduct the survey, but Voalte compiled, analyzed, developed and released the findings.

The survey of 513 nurses (226 nurse leaders and 287 staff nurses) looked at technology and communication in nursing workflow. Voalte surveyed 1,122 nurses, but chose to report only on the 513 who worked in acute care settings.

While a number of studies and surveys have been done about device use by doctors in a hospital setting, it’s less common to see studies focused on nursing. For instance, a recent study by Deloitte found that 43 percent of physicians used smartphones for clinical purposes.

The Voalte study found that, at work, 81 percent of nurses had access to a landline phone, 40 percent had access to a non-smartphone mobile phone and 41 percent had access to a pager or beeper.

Beyond device availability, the study looked more broadly at nurses’ perceptions of communication in the hospital.

“Our objective was to describe the perceptions of nurse leaders and staff nurses regarding how nurses communicate, the time they spend communicating and their barriers to communication,” the authors write in the executive summary. “We explored how those perceptions relate to other nurse activities such as communication inside and outside the hospital, charting and technology decision-making. We were also interested in discovering how the communication challenges perceived by nurse leaders aligned with the perceptions of nurses at the bedside.”

For instance, when asked what their biggest communication challenge was, 47 percent of staff nurses cited unnecessary interruptions, as opposed to only 11 percent of nurse leaders. But 58 percent of nurse leaders said a lack of communication devices was the biggest problem, compared to only 9 percent of staff nurses.

Nurses weighed in on how much influence they have over technology decisions. While 86 percent of leaders and 78 percent of staff nurses believe the chief nursing officer influences technology, only 47 percent of nurse leaders and 20 percent of staff nurses say that staff nurses have a chance to evaluate devices.

The survey compared nurses who carried zero, one, two, or three devices in terms of how likely they were to experience a technological barrier to communication. Nurses who carried a single device experienced barriers the least often (52 percent reported encountering barriers 25 percent of the time or less). In addition, nurses who had access to texting reported fewer communication barriers.

Finally, nurses reported that access to clinical communication devices improved their ability to provide care. Fifty-eight percent of nurse leaders and 42 percent of staff nurses said more time spent at the bedside was the biggest impact of clinical communication devices, while 28 percent of nurse leaders and 32 percent of staff nurses cited fewer errors as the biggest impact.

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FDA wants to know why uChek app doesn’t have clearance

By: Brian Dolan | May 22, 2013        

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Biosense uChek appThis week the US Food and Drug Administration sent a letter to Mountain View, California-based Biosense Technologies, maker of the uChek smartphone-enabled urinanalysis system, that instructs the company to seek 510(k) clearance of its mobile medical app or convince the FDA that such a clearance is not necessary. Sending an ”it has come to our attention letter” like this is a rare action for the agency.

Biosense’s uChek system includes an iPhone app and a color-coded mat. It works with a handful of already FDA cleared test strips from Siemens and Bayer. The uChek user puts the test strip on the mat — which contains color samples to normalize lighting conditions — and then snaps a picture with their smartphone camera. The app analyzes the strip colors against the swatches on the mat, and returns data about glucose, protein, ketone levels, and more in the sample as well as diseases detected. The user can save readings and track data over time.

“Please note that though the types of urinalysis dipsticks you reference for use with your application are cleared, they are only cleared when interpreted by direct visual reading,” James Woods, a deputy director with the FDA, politely stated in the letter. “Since your app allows a mobile phone to analyze the dipsticks, the phone and device as a whole functions as an automated strip reader. When these dipsticks are read by an automated strip reader, the dipsticks require new clearance as part of the test system. Therefore, any company intending to promote their device for use in analyzing, reading, and/or interpreting these dipsticks need to obtain clearance for the entire urinalysis test system (i.e., the strip reader and the test strips, as used together).”

On Biosense’s FAQ section of its website, the company explains that:

uChek iPhone app“Yes, uChek is a medical device. It is for In Vitro Diagnostic Use only and only to be used by or on the recommendation of a qualified healthcare professional. Biosense Technologies Pvt Ltd, the manufacturer of the uChek urine analyzer is a FDA registered facility and the uChek urine analyzer is a medical device registered under Product Code KQO, and as per regulation 862.2900 of the FDA.”

In his letter Woods goes on to explain that the FDA has reviewed its database of cleared and registered medical devices and could not find one for uChek. He then asks Biosense to provide the FDA with appropriate information or to provide the FDA with an argument for why it does not require registration or clearance. The company has 30 days to respond.

Woods also points Biosense to a summary clearance document for a similar medical device that analyzes urine test strips. As of this writing the uChek app is still available in Apple’s AppStore.

uChek gained a considerable following after Biosense Technologies Co-Founder Myshkin Ingawale demonstrated the app during a TED talk earlier this year. Since then the application has received considerable press attention and, notably, was mentioned as an example of an app the FDA might be failing to regulate appropriately during the FDA medical app congressional hearings this past February.

If the letter from the FDA does result in Apple removing uChek from the AppStore (even if it’s a temporary exile), the urinalysis app would be one of the few known examples of apps to be taken down because of such an action. Most famously, MIM Software’s Mobile MIM imaging app, which was demo’d onstage at Apple’s 2008 World Wide Developers Conference — the one that kicked off the launch of the AppStore, was removed from the AppStore in the months to follow because the FDA believed it might need clearance as a medical device. It ended up taking MIM two years to secure clearance.

While the FDA clearance process for mobile medical apps is still far from efficient, the agency has given the issue much more attention in recent years. The fate of Bionsense’s urinanalysis app will serve as an important bellweather for the current regulatory climate for mobile medical apps.

For more on FDA regulation of mobile medical apps, head over to our Research Store for the MobiHealthNews report: 75 FDA Regulated Mobile Medical Apps.

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Scanadu to crowdfund its tricorder device pre-FDA clearance

By: Jonah Comstock | May 22, 2013        

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Scanadu

The updated Scanadu Scout.

San Francisco-based Scanadu, which had planned to release it’s tricorder-like SCOUT device by the end of 2013, is launching an Indiegogo campaign to sell the device. In an unprecedented move, the company is launching its crowdfunding campaign without FDA 510(k) clearance, with the intention of conducting the usability tests needed to get the clearance via the campaign.

“It’s sold as a research device for investigational use. Everyone who buys it is essentially a researcher in that project,” Scanadu CEO Walter De Brouwer told MobiHealthNews. “I think that crowdsourcing and crowdfunding will give rise to a lot of new ways to look at business, manufacturing, and even legal aspects.”

The usability study will also include a board of doctors, headed up by high-profile pediatrician and Scanadu chief medical officer Dr. Alan Greene. There are no requirements for participating funders except that they be willing to report on how the device functions once they get it. Although the device’s design is more or less locked in, contributors’ data will help the company fine-tune the scanning algorithms and provide them with information about feasibility, usability, and consumer friendliness. In addition, backers will have the option to opt in to clinical studies that Scanadu will set up in the future.

The Scout will sell for $149 (hitherto the company’s target retail price) to the first 1,000 supporters, and for $199 to others, and will ship in the first quarter of 2014. In addition to discounted devices, perks in the campaign will include visits and tours of the NASA-Ames Research Center where Scanadu is based.

The device has been redesigned in several key ways since the prototype was unveiled last November. Though the company hasn’t started selling the product yet, they have heard from potential consumers about their designs.

“People wanted not only to scan themselves, but also wanted to scan others, so they can talk about healthcare and give tips and tricks and take it on travels. So we decided to take a year to design it again on the bench, and we made alterations so they can also scan others,” De Brouwer said. The old design of the device only worked on the person using it because it required making a closed circuit between the user’s fingers and his or her temple.

The company also added additional sensors and upgraded from an 8-bit to a 32-bit processor. Additionally, the new Scout will run the Micrium operating system, the same OS used for sample analysis on NASA’s Curiosity Mars rover. Aesthetically, the device has been tweaked and is now circular, rather than diamond-shaped.

ScanaFlo and ScanaFlu still on the way

Scanaflo

The ScanaFlo urine test peripheral.

Meanwhile, the two peripheral devices Scanadu announced in November when it debuted its suite are also coming along the road to regulatory clearance, according to De Brouwer. The company just unveiled designs for the ScanaFlo, the company’s urine testing peripheral. The device is a disposable paddle with a QR code printed on it. It will test for for levels of glucose, protein, leukocytes, nitrates, blood, bilirubin, urobilinogen, specific gravity, and pH in urine, as well as for pregnancy, and the readout will be integrated into the Scanadu Scout app.

The company has received 6,000 of the paddles from the manufacturer and is beginning clinical trials. They hope to submit for FDA 510(k) clearance at the start of July.

De Brouwer said the other product, a saliva-based influenza test called ScanaFlu, has to undergo its clinical trials during flu season, which puts it on a later timetable generally. The company plans to start large clinical trials for ScanaFlu — with thousands of patients — in October 2014.

On track for the X Prize

De Brouwer said Scanadu continues to be in good shape to meet the requirements of the Qualcomm Tricorder X Prize.

“For the moment, the X Prize consists of 3 layers,” he said. “The first set is the vital signs. You have to measure three out of five, we measure five out of five, so we’re completely ready. Then there’s this set of diseases you have to choose from: there are 12 diseases, we can cover, with what we have in the lab and with separate sensors, we can cover seven. And then for the elective set, you have to choose three (additional conditions) and there we’ve covered two. So we are on track.”

You can see the new video Scanadu put together for the crowdfunding campaign here.

UPDATE 9:15 AM: Just over one hour into the campaign, Scanadu has already raised 50 percent of its $100,000 funding goal.

UPDATE 10:15 AM: Entering hour three of the campaign, the company has already surpassed its funding goal. About half of the discounted Scouts are claimed.

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