Tags: Australia mHealth | CE Mark | Entra Health Systems | FDA 510(k) | Health Canada | MyGlucoHealth | Nokia | Telstra |
Entra Health Systems, creator of MyGlucoHealth, announced last week that it has received Health Canada’s Therapeutic Products Directorate (TPD) clearance for the sale of its Bluetooth-enabled glucose meter in the country. MyGlucoHealth meters and test strips will be available for purchase in Canada immediately. The device secured FDA clearance and a CE Mark in 2009. MyGlucoHealth also launched in Australia through a partnership with one of the largest mobile operators in that country at the end of 2009.
Entra’s MyGlucoHealth meter offers wireless transmission of test results via Bluetooth to a patient’s phone. The company also offers the MyGlucoHealth Patient Analytics Portal, which gives patients, clinicians and caregivers access to patient data both from the desktop and mobile phone. Entra Health partnered with Nokia last year to develop diabetes management apps for Nokia phones.
“Canada represents a strong market opportunity for MyGlucoHealth,” stated Entra Health CEO Richard Strobridge in a press release. “We have achieved significant success in the U.S. and the Asia Pacific to date. Our goal is to establish a strong regional infrastructure for support continued growth as we expand internationally.”
Read the full press release after the jump.
Tags: AliveCor | Burrill & Company | Dr David Albert | iPhone ECG | Oklahoma Life Sciences Fund | Qualcomm Ventures |
AliveCor, developer of the iPhone ECG, announced this week that it has raised $3 million in its first round of funding. The investment was funded by Burrill & Company, Qualcomm Ventures and the Oklahoma Life Sciences Fund.
The company plans to use the investment to expand its team, gain regulatory approval and market the device worldwide. AliveCor expects to commercially launch its iPhone ECG case (pictured) and wireless iCard later this year. The devices will cost less than $100, according to AliveCor founder Dr. David Albert. Both devices will still need to complete a clinical trial and secure FDA 510(k) clearance. The company is working with OU Health Sciences Centers.
The iPhone ECG first got notice in late December 2010 when Albert uploaded a video demo of the device to YouTube. The video went viral and made the device one of the most talked about at the Consumer Electronics Show in January. The video has since received more than 250,000 views. MobiHealthNews first spoke to Albert about the iPhone ECG in January. AliveCor expects to offer a free iPhone app for patients, with a paid version for physicians. Sometime after the iPhone ECG case becomes commercially available, the company plans to launch the iCard, which works with other iOS and Android devices. (Albert spoke to MobiHealthNews about the iPad’s role in healthcare in March.)
“The iPhone ECG captured the imagination of the world at CES by demonstrating the power of personal health monitoring as enabled by the Apple iPhone and other smartphones,” Albert stated in a press release. “AliveCor looks forward to taking our innovations to all parts of the world for physicians, emergency first responders and patients alike.”
Interestingly, while the iPhone ECG strongly associated with the iPhone, Dr. Albert’s AliveCor Australian co-founders Bruce Satchwell and Kim Barnett began working on the ECG device in 2005, which is well before the iPhone launched. The Oklahoma City Chamber of Commerce originally helped bring the business to Oklahoma City in 2008, the press release stated.
For more on the investors and AliveCor, read the press release after the jump.
Tags: 3G blood glucose meter | blood glucose meter | FDA 510(k) | FDA mobile medical apps | FDA Telcare | Telcare |
According to an FDA filing, wireless-enabled blood glucose meter developer Telcare just received 510(k) clearance for its device, Telcare BGM. The company submitted its device for FDA review at the beginning of March.
Telcare has largely eschewed the glucometer-smartphone pairing model currently pursued by a number of other device makers in favor of a wireless meter “that requires no additional investment.”
Telcare’s device is cellular-connected and according to the company it is “merely a replacement of older technology for which insurers already pay.”
The Telcare BGM includes 3G cellular connectivity that send glucose tracking data to the company’s clinical server. Telcare is also developing a suite of smartphone apps, which might be used by caregivers, including “parents of children with diabetes and those caring for elderly people with diabetes,” to better manage their loved ones.
“Moreover, the Telcare blood glucose meter significantly increases the work productivity of disease management personnel who no longer need to spend time calling patients to ask for glucose data and can now relay simple coaching directly on the Telcare blood glucose meter platform instead of using less efficient means of outbound communication,” Telcare states on its website. The company says the device can send data directly to electronic health records (EHRs).
Telcare has previously stated that it plans to offer its blood glucose meter offering to customers at the same pricepoint of “disconnected” devices that are already on the market.
The company has raised about $4.5 million in funding to date from investors including Qualcomm Ventures. It also works with Sierra Wireless for its device’s connectivity. (Update: Sierra is not an investor in the company.)
Learn more about the Telcare executive team (led by Jonathan Javitt MD MPH) at Telcare’s site.
Tags: AT&T WellDoc DiabetesManager | WellDoc | WellDoc DiabetesManager |
WellDoc released this week the pre-print version of the first randomized controlled trial (RCT) study using a mHealth solution (WellDoc’s DiabetesManager) to track reduction in blood glucose levels over one year compared against usual methods. According to the study results, “the mean decline in A1C (the gold-standard measure for diabetes control) was 1.9% in the intervention group and 0.7% in the usual care group, a difference of 1.2%.”
The Mobile Diabetes Intervention Study (MDIS), conducted by the University of Maryland School of Medicine, is scheduled to be published in the September issue of the American Diabetes Association’s (ADA) publication Diabetes Care.
“We studied the impact of combining web and mobile based patient coaching with clinical decision support for community primary care providers, and compared this approach with standard diabetes management or usual care alone.” stated Charlene C. Quinn, RN, PhD, University of Maryland School of Medicine and lead investigator of the study, in a press release. “The trial results indicate that doctors and patients can engage more effectively using mobile health tools like the WellDoc system to enhance patients’ diabetes care and their blood glucose.” According to the study, a clinically significant change in A1C occurred whether patients began the trial with a high or low A1C.
WellDoc is set to release the WellDoc DiabetesManager commercially this fall, which received FDA clearance one year ago. They announced integration with Allscripts EHR last December and a partnership with AT&T last fall. Back in 2009, WellDoc published the results of a three month study using their Virtual Coach monitoring software that had a 2% reduction in A1C compared to a control group.
Read the full press release after the jump. Keep reading>>
Tags: ADAM Corp. | ADAM Medzio | Health at Hand | Highmark Blue Cross Blue Shield | iPhone medical app | Medzio | smartphone health app |
Health insurer Highmark plans to launch a new mobile app for its members early next year, Lisa Fitting, Director of Digital Client Engagement at Highmark told attendees this morning at the World Congress Leadership Summit on mHealth in Boston. Highmark partnered up with A.D.A.M. last year to build a pilot app called Health@Hand based on A.D.A.M.’s Medzio app.
Health@Hand was similar to Medzio but also included customized information for Highmark members that enabled them to find healthcare services and physicians available within their plan. Users could search for providers within a certain radius of their current location using their phone’s GPS and subsequently get a map and directions to the provider via the app. Like Medzio, the app also included a symptom navigator and other health information resources.
Fitting said the new app will have additional core functionalities, including an “authenticated” section which will include personalized information about the user. Part of the offering will include a “digital ID card” and a more advanced provider search built into the app.
Fitting said Highmark is planning to sunset its pilot app, Health@Hand in anticipation of the launch of its new app.
Fitting said that Health@Hand had a number of shortcomings, including user interaction design, no feedback mechanism, and an unclear branding strategy.
The new app from Highmark will include a way for users to shop for insurance, Fitting said. The health plan aims to generate revenue from the app.
Following the launch of the new app during the first quarter of 2012, Fitting said that Highmark plans to develop other complementary apps over the course of the year.
Tags: Gran and Gran | Humana | HumanaVitality | Raja Rajamannar | World Congress Leadership Summit mHealth |
During the opening keynote at the The World Congress 3rd Annual Leadership Summit on mHealth, Raja Rajamannar, SVP and Chief Innovation and Marketing Officer at Humana, spoke about Humana’s consumer-focused approach to well-being, which aims to use gamification to “make healthy things fun and fun things healthy.” Humana wants to enable consumers in six dimensions: activity, nutrition, connection, timely access, convenience, and compliance.
“I came into this industry with no baggage,” Rajamannar said during the beginning of his keynote. “I have a consumer background. Lots of things that are good for you are boring and painful; lots of things [that are] bad for you give immediate gratification. What tools do we have to change this?”
Rajamannar then discussed a number of mobile-focused programs that the company is now involved in.
One of the highlights included a concept for a bicycle that measures the rider’s weight, pulse, oximeter, and other biometrics, calculating the effort the rider is making on the bike based on their biometric data. Humana is working with bike maker Trek on the project. Keep reading>>