WellDoc adds oncology expertise with acquisition

By: Brian Dolan | Feb 7, 2011        

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WellDoc Oncology ManagerWellDoc continues to make moves. This morning the Baltimore-based company acquired home health consulting company Oncology Care Home Health Specialists for an undisclosed sum. The move will help WellDoc more quickly develop its oncology solution, which it expects will be a complement to its already FDA-approved DiabetesManager.

WellDoc has integrated Oncology Care’s proprietary intellectual property and care algorithms into its own WellDoc Automated Expert Analytics System, which better positions WellDoc to offer coaching and clinical support to cancer patients and their providers over the Internet and through mobile phones.

WellDoc has repositioned the oncology company as a subsidiary and has shortened its name to Oncology Care Home Health, which it now describes as a “comprehensive education and consulting company dedicated to helping home health providers implement specialized oncology programs.”

According to the American Society of Clinical Oncology there are only 12,500 oncologists projected to be available to provide care by 2020, which marks about 4,080 oncologists fewer than needed.

“The only way to close this gap in care is through the use of technologies such as those from WellDoc,” Georgia M. Decker, APRN, ANP-BC, AOCN, past president, Oncology Nursing Society, stated. “We need solutions that support evidence based clinical decisions and also virtually extend the clinicians’ care plan to the patients’ mobile phone.”

WellDoc expects to market the oncology service through its AT&T channel and other undisclosed pharmaceutical sales channels. With this announcement WellDoc has kept up its momentum. In recent months it secured FDA approval for DiabetesManager, inked a deal with AT&T and integrated with a leading electronic health records (EHR) system.

For more on the acquisition, read the press release after the cut. Keep reading>>

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Smartphone medical apps roundup: Cisco, Novo, Voalte, iTriage, pMDsoft and more

By: Brian Dolan | Feb 5, 2011        

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pMDsoft iPadFDA to regulate nurse paging offering? Certainly an interesting development: Cisco subsidiary Extension submitted its HealthAlert for Nurses offering to the FDA for product clearance. HealthAlert relays critical alerts to a nurse’s Cisco IP handset, or preferred smartphone device. The FDA has already informed Extension that there is no communications tool on the market that is “substantially equivalent” to HealthAlert for Nurses, which puts it into the Class III Medical Device category: “This submission for FDA clearance culminates two years of research and tremendous effort designed to differentiate Extension from similar – but certainly not equal products – currently available in the marketplace. It also offers comfort to our growing hospital client base seeking to utilize their existing Cisco infrastructure and/or the emergence of smartphones, and serves as future-proofing for our clients and partners in the face of more FDA regulation in the middleware communication space. I think everyone in the industry agrees more FDA regulation in mobile health and communication is on the horizon. We’ve positioned ourselves well ahead of the pack both for Cisco IP-based handsets and smartphones,” stated Extension CEO Todd Plesko. More

Diagnose bleeding disorders: Novo Nordisk launched a new app called Coags Uncomplicated, which assists in the diagnosis of bleeding disorders. Novo developed it with help from Craig Kessler, MD, Professor of Medicine and Pathology and Director of the Coagulation Laboratory, Georgetown University Hospital, Lombardi Comprehensive Cancer Center. More

Mobile charge capture: pMDsoft has upgraded its mobile charge capture native application for doctors using iPads in addition to an iPhone, iPod Touch or BlackBerry. Based on feedback from users, pMDsoft re-engineered the app to enable doctors to use their account simultaneously on both their iPad and a smartphone. More

Nurse text, alerts and voice: A few weeks ago Voalte inked its biggest deal to date when it signed up Texas Children’s Hospital — the largest pediatric hospital in the country. That’s 500 handsets running Voalte’s voice, alarm, text software for nurses. More

FDA clears first diagnostic radiology app, Mobile MIM

By: Brian Dolan | Feb 4, 2011        

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MIMViewer iPad medical appsMobile MIM was one of the very first medical applications to debut in Apple’s AppStore when it first launched in 2008, but the application also has the distinction of being the first medical application pulled from the store because of regulatory concerns. Today those concerns are over: The US Food and Drug Administration has officially granted the mobile radiology application a 510(k) clearance.

“The application is the first cleared by the FDA for viewing images and making medical diagnoses based on computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine technology, such as positron emission tomography (PET),” the FDA stated in a press release this morning. “It is not intended to replace full workstations and is indicated for use only when there is no access to a workstation.”

The app enables clinicians to measure distance, intensity values, display measurement lines, annotations and regions of interest. The images are securely transferred to the app from a hospital or physician’s office through a secure network transfer facilitated by MIM.

“The display performance of mobile devices can experience significant variations in luminance levels even between mobile devices of the same model,” the FDA wrote in its press release. “The Mobile MIM application includes sufficient labeling and safety features to mitigate the risk of poor image display due to improper screen luminance or lighting conditions. The device includes an interactive contrast test in which a small part of the screen is a slightly different shade than the rest of the screen. If the physician can identify and tap this portion of the screen, then the lighting conditions are not interfering with the physician’s ability to discern subtle differences in contrast. In addition, a safety guide is included within the application.”

Mobile MIM was one of the only iPhone apps demonstrated during Apple’s keynote presentation that launched the Apple AppStore back in the summer of 2008.

“Of course, we were thrilled,” MIM Software CTO Mark Cain told MobiHealthNews in an interview last year. “We were one of eleven developers that presented during the keynote. That week we won an Apple Design Award for Best iPhone Healthcare & Fitness Application.”

That August MIM submitted their 501(k) for Mobile MIM and after some discussions with the FDA decided they had to remove Mobile MIM from Apple’s AppStore: “Then, over the next few months, we discovered that our proposed device raised more questions than we had anticipated. In order to make their determination, the FDA wanted more information than we had provided,” Cain explained to MobiHealthNews last March. “The process stalled out as we reviewed what we would have to do next. This 510(k) was declared not substantially equivalent (NSE) because of insufficient data.”

In June 2009 MIM resubmitted a 510(k) with more data from trials. After 221 days the FDA again deemed the app NSE: The FDA’s official position was that “displaying medical images for diagnostic use on a mobile/portable device” is a new intended use without predicate, and as such is a class III (premarket approval) medical device, according to Cain.

Luckily for MIM, the FDA’s opinion on that matter must have changed in the intervening months because today Mobile MIM has a 510(k) clearance. MIM’s experience is one of the few public accounts of the nuances of FDA regulation of mobile health services. The clearance some two and a half years later of an app that originally launched with Apple’s AppStore is surely a milestone for mobile health.

The industry — and the FDA — have come a long way since 2008. Read the FDA’s full press release below: Keep reading>>

FDA approves Mobisante’s smartphone ultrasound

By: Brian Dolan | Feb 4, 2011        

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Mobisante MobiUS smartphone ultrasoundA steady procession of mobile health devices continues to march through the FDA’s regulatory process.

The US Food and Drug Administration has granted Redmond, Washington-based mobile health start-up Mobisante 510(k) clearance for its smartphone-based ultrasound system, MobiUS.

Dr. Sailesh Chutani, CEO and co-Founder of Mobisante, was previously an executive at Microsoft. Before founding Mobisante in 2007, Chutani created Microsoft’s mHealth initiative in 2006, but the group was not called that because the term was not yet widely used. As part of his responsibilities at Microsoft, Chutani managed $100 million of investments in emerging markets for the company.

The mobile ultrasound imaging system will cost between $7,000 and $8,000 in full, which includes a Toshiba Windows Mobile-powered smartphone, an ultrasound probe and the company’s software. Mobisante hopes to halve the cost of the system over time, but the pricetag is still much lower than the tens of thousands or in some cases more than $100,000 other ultrasound systems cost today.

Mobisante’s device is intended for ultrasound imaging, analysis and measurement in fetal/OB, abdominal, cardiac, pelvic, pediatric, mucoskeletal, and peripheral vessel imaging. The smartphone-based ultrasound system can leverage both cellular and WiFi to send images for diagnosis, second opinion, or to a Picture Archiving and Communication System (PACS) for storage. Keep reading>>

Mobile health IPOs, acquisitions, and investments

By: Brian Dolan | Feb 3, 2011        

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Brian Dolan, Editor, MobiHealthNewsThree important stories broke on the same day this week: Epocrates went public and raised $86.4 million; Dr. Patrick Soon-Shiong acquired GlowCap-maker Vitality for some unnamed tens of millions of dollars; A stealthy mobile-focused startup named Massive Health launched.

Which of these will prove to be the most important longterm?

Obviously the Epocrates IPO is a massive boon to mobile health, but it has been a long time coming. Epocrates filed its first offering in 2007. The company joins a very small club of public companies focused on mobile health. CardioNet is one of Epocrates few public company compatriots, though the two sit on near opposite sides of the wireless health spectrum: Mobile content for physicians and wireless-enabled monitoring of patients. Just as CardioNet founder Jim Sweeney has continued to innovate in mobile health, I expect the founders and executives of Epocrates to make their exits over time and lead new startups in the space. Epocrates co-founder Jeff Tangney is a good example: He launched Doximity last year. Epocrates’ listing on NASDAQ won’t be all that transformative for mobile health, however. Few wireless health companies are in a position to follow Epocrates anytime soon, either.

The acquisition of Vitality may be another story. Thanks to a consumer focus (no FDA clearance required), a grade A efficacy report from Partners (98 percent adherence!), and the backing of one of the largest telecom companies around (AT&T), Vitality’s GlowCaps were likely to drive it to early acquisition. Billionaire and UCLA Wireless Health Institute director Dr. Patrick Soon-Shiong is an ideal buyer. You can bet the good doctor is just getting started, too. More acquisitions are likely. A mobile health roll-up could very well be underway.

In the span of just six weeks Aza Raskin and Sutha Kamal managed to convince a stable of investors including Andresseen Horowitz, Mohr Davidow Ventures and others to seed their newly formed startup, Massive Health, with $2.25 million. Massive Health’s founders have promised to bring a “design Renaissance” to healthcare starting with smartphone apps for chronic disease management. Raskin was most recently the creative lead at Mozilla, which developed the Firefox web browser. The launch of Massive Health received unusual attention from the big tech blogs, because of the founders’ Silicon Valley credentials, the size of the seed round, and the high profile group of investors. Xconomy learned that self-insured employers are a likely direction for Massive’s business model. GigaOM closes with a prediction that mobile health is going “to get even more crowded” as more venture capitalists will begin to take a look. Did Massive Health’s launch wake up investors?

So, which is it: The IPO, the acquisition, the investment or none of the above? Which will have the most impact on mobile health in the longterm?

US digital health hits $1.7 billion in 2010

By: Brian Dolan | Feb 3, 2011        

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Revenues from the digital health market in the US topped $1.7 billion last year, according to a new report from Parks Associates. The research firm believes that the market will generate revenues of more than $5.7 billion in 2015. The growth will be fueled by chronic care management services, aging in place applications and wellness and fitness apps, Parks believes.

“The digital health industry has many subsectors, and near-term growth will be uneven across these segments,” Harry Wang, director of Parks Associates’ health research team stated in a company release. “Adoption of chronic-care monitoring will grow slowly, and medication management and senior fall-detection programs will expand at above-average rates. The real engines of growth will be mobile care solutions and tracking applications.”

Last April Parks Associates released a report that found the wireless home health market was about $304 million in 2009. The report predicted that the market would top $4.4 billion by 2013.

There are a number of different ways to slice the market — remote monitoring, consumer health, digital health — or by technology, specifically WiFi vs. cellular. Last year we noted that various estimates for mobile health related revenues could top anywhere from $1.9 billion to $6 billion depending on how the market was defined.