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.”


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.

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.

Scanadu to crowdfund its tricorder device pre-FDA clearance

By: Jonah Comstock | May 22, 2013        

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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


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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Understanding Cigna’s evolving digital health strategy

By: Brian Dolan | May 21, 2013        

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Brian Dolan, Editor, MobiHealthNewsDuring the last few years health insurance companies have shifted from an employer-focused mindset to one that is increasingly consumer-, member-, or individual-focused. The move toward consumer engagement, Cigna’s Director of IT Strategy and Innovation Willis Gee told MobiHealthNews, is being driven by cost and quality pressures, new benefits models and growing information intensity.

Nearly all health plans and payors these days point to some permutation of a “triple aim” of affordability, satisfaction, and quality as their mandates. For its part, Cigna says it is looking outside the healthcare industry to take cues from leading consumer companies like Amazon, eBay, and Bank of America, as it continues to develop its consumer engagement strategy to help it achieve those aims.

At the core of Cigna’s strategy is what the company internally refers to as its “Know Me Engine”, which is made up of all the various ways the company collects data on its members, including data from traditional sources like health claims and lab data but also newer sources like answers to gamified health risk assessments or data collected by what Gee calls “instrumentation devices”, or what are popularly referred to as quantified self tools.

The Know Me Engine “is our way of building a platform that takes into consideration the likes, preferences, and dislikes that a member has, which we then wrap around a platform we call ‘Health View’, our longitudinal view of a member that takes into consideration all of our interactions with them, all of the data we collect, so that we can personalize the experience for that individual.”

“Ultimately, it is about meeting customers where they are,” Gee said. “That is where we are starting to see the intersection between mobile, gamification — which is becoming an increasingly interesting area for us — social media, and big data — another buzz word you are starting to see a lot more.”

Mobile is very important to Cigna’s consumer engagement strategy, Gee said, after pointing out that there are now more mobile phones in the US than there are people. He also noted that there will be more internet searches conducted from mobile devices in two to three years than from desktops. Cigna has taken many of its digital assets mobile, including its provider director, health risk assessments, and even some telehealth services are moving to the company’s mobile apps.

The myCigna app for Android and iOS users includes a laundry list of features, like personalized benefits information, personalized claims, provider directory, cost and quality tools that cover hospitals, physicians, and drug comparisons. Gee characterizes those as some of the core customer services capabilities. Beyond that Cigna is beginning to extend some consumer decision support and condition management tools to its mobile app.

One example, Gee said, was its gamified health risk assessment that the company partnered with Audax Health to develop.

“We took a rather mundane task of a health risk assessment and we’re asking questions in a different way,” he said. “Historically, you’d go through a survey of 60 questions about your health. With this tool you go through a very slimmed down list of questions like: What would you rather eat: A slice of pizza or a salad? Would you prefer to take a nap or prefer to take a run? These tease out information about that person to create an online profile for them, which then allows us to really target what personal goals and objectives they have.”

Members who take the HSA then receive incentives that they can redeem as rewards for positive health behaviors — all through the mobile platform, Gee said, which is rare for health risk assessments.

“The other technology we are starting to introduce within our mobile platform is telehealth,” Gee said, alluding to Cigna’s recent deal with MDLive. “Video conferencing, click to chat, click to email, are capabilities we are building out in the very near future. People check their cell phones 100 to 150 times per day. For us, mobile is where we need to thrive.”

Another key area of focus for Cigna’s consumer engagement strategy is gamification.

“Historically, healthcare, has not been leveraging games to engage customers,” Gee said, “but look at how ubiquitous it is, something like 70 percent of mobile phone owners are playing games on them. Just look at how many of our households have game consoles in them. [Gaming] is a way that we can reach people in a unique way that really starts to integrate and become a part of their daily life, which is ultimately what we need to do.”

Gee pointed to Cigna’s longtime work on healthy gaming with Hope Lab, where it has helped to develop games for people with cancer and the exergaming system Zamzee, which is fighting childhood obesity and inactivity.

When it comes to social networking, Gee said Cigna mostly uses the big channels like other consumer-facing brands: “cautiously”. Facebook and Twitter are great channels to connect with members to mostly learn about ways they could improve their products and better understand how their customer service is faring. Gee said Cigna is looking for ways to leverage social networks that are “not intrusive and, for lack of a better term, not creepy.”

More intimate and focused social networks, like the ones Cigna and BodyMedia are creating for people managing diabetes, seem to have more promise. Gee confirmed that the pilot, which was announced before BodyMedia’s acquisition by Jawbone earlier this year, is still underway. Cigna is developing infrastructure that Gee says will be device agnostic so that its members are able to use any tracking devices they choose, but also to keep up with what the company realizes is an ever-changing quantified self device landscape.

Tracking devices are an important part of Cigna’s social network strategy but also its big data plans, according to Gee.

“With big data, I think the technology itself is important,” Gee said, “but as we start to take data from a variety of sources whether through structured or unstructured data — information from personal instrumentation devices, like a Fitbit or Nike+ FuelBand — that’s where we can start to get a lot more insight about our customers.” Gee said this data could “ultimately redefine their customer service experience and also redefine their care process.”

These devices, of course, can also enable telehealth services: “This is a very exciting space when you think about the sleep monitor devices, activity and fitness devices, and even something like pulse oximetry,” Gee said. “Just think about someone with COPD who can use that device to collect their pulse ox, have it connect to their smartphone and send that to their physician to have them view it remotely. That, to me, is the future of where we are bringing the ICU to the member and not the other way around.”

All of these tools and devices are “interesting”, Gee said, but they become “extremely relevant” when you integrate them into a care plan and they begin to inform providers. That deeper integration is the next phase of development for Cigna’s consumer engagement strategy. In the meantime, the company is also looking to work with or learn from digital health companies that “have a unique way of engaging customers,” Gee said. Healthcare consumers can not be approached with a one-size-fits-all strategy, he said, and Cigna wants to talk to companies who have successfully found ways to engage patients of different ages, from different cultures, and with different health issues.

Android medical dictionary promises to save $2,300 per doc

By: Neil Versel | May 21, 2013        

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Adaptxt MedicalFollowing the same notion that speech recognition technology vendors have had about medicine needing customized electronic dictionaries to handle the specialized vocabulary, a British company is bringing medical terminology to texting and mobile typing – and positioning its product as a big money-saver.

KeyPoint Technologies, based in Glasgow, Scotland, this week introduced a set of industry-specific dictionaries for Android smartphones and tablets, including a medical version called Adaptxt Medical that contains a database of 15,000 specialized terms. Many of these words relate to anatomy, disease names and drug names.

The company estimates that the Adaptxt Medical app can save practices thousands of dollars per physician, based on the assumption that 10,000 of those terms do not appear in general dictionaries and that it takes 10 seconds to enter each word into a phone’s vocabulary list to prevent embarrassing “autocorrect” errors. At a median hourly wage of $85.26 for a general practitioner in the US, the data entry and correction of errors amounts to $2,368.50 in lost productivity per primary care physician, according to KeyPoint, which has US headquarters in San Jose, Calif.

“It needs to be addressed,” KeyPoint marketing VP Ronald Brown said of the autocorrect problem.

The medical app, like the other new vocabulary sets for legal, finance, business and general IT professionals, applies algorithms and artificial intelligence to pick up on each user’s unique typing patterns and add words to that person’s dictionary, Brown told MobiHealthNews.

KeyPoint Technologies makes Adaptxt dictionaries in 78 languages, including many with holiday and sports themes, that run on top of a free keyboard app. Each, including the industry-specific dictionaries, sells for 99 cents in the Google Play store.

Currently, KeyPoint only has apps for Android devices. “There’s more flexibility with Android,” Brown says. An Apple iOS keyboard app is in the works, and the company also is looking to develop BlackBerry and Windows Phone versions, though Brown would not say what stage of development those projects are in.

“Expect to see more in healthcare,” Brown added, though he declined to share specifics.