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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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.”

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.