Sotera Wireless gets FDA nod for mobile vital sign monitor

By: Brian Dolan | Apr 17, 2012        

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Sotera Wireless Visi MobileAs we noted in our recently published Mobile Health: State of the Industry Q1 2012 report, late last month the FDA granted Sotera Wireless 510(k) clearance for its wearable vital signs monitoring device, the ViSi Mobile Monitoring system. Sotera submitted the system to the FDA last August and received Class II 510(k) clearance on March 22nd of this year.

According to the company, “the ViSi Mobile Monitoring System is a lightweight, portable patient vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is body-worn and designed to continuously measure ECG, heart rate, SpO2, pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable on demand. NIBP can be measured as a onetime measurement, or it can be measured automatically at predefined intervals.”

Update: The version of the ViSi system that received FDA clearance does not include wireless transmission of data to computers or mobile devices for alerts, secondary viewing, or connectivity with EMR systems. It also does not include the company’s patented cuffless non-invasive blood pressure (cNIBP) sensor. Future versions of ViSi will include both, the company noted in a press release published Wednesday.

Here’s how the summary document from the FDA describes the system’s intended use:

“The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients. It is indicated for ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (H-R), non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2 ), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including general medical-surgical floors, intermediate care floors, and emergency departments.”

While the device’s initial intended use is for inside healthcare facilities, the device will likely migrate to outpatient settings and eventually the home.

Sotera has already scooped up about $50 million in funding from various investors including Singapore-based global fund EDBI, Cerner Capital, Sanderling Ventures, Qualcomm Ventures, Intel Capital and the West Health Investment Fund. The company also already has a commercial partnership with Cerner and it has also collaborated with San Diego-based Palomar Pomerado Health to integrate its vital signs monitoring devices with Palomar’s Medical Information Anytime Anywhere (MIAA) platform, which aims to provide clinicians with access to patient medical records and vital sign information in real time or near-real time.

MobiHealthNews has been tracking Sotera for many years: Back in 2009 we noted that Sotera Wireless had changed its name from Triage Wireless as part of an agreement with Inverness Medical Innovations, which markets products under the Triage brand.

More news from the first quarter of 2012 in our Mobile Health State of the Industry Report here.
More on Sotera’s FDA clearance in this FDA 510(k) summary document. (PDF)
Update: Read more details in Sotera’s press release, below: Keep reading>>


Global mobile health market worth $8B by 2018

By: Brian Dolan | Apr 16, 2012        

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Money TreeA recent report from Global Data pegged the global mHealth market as having a $500 million value in 2010 that will top $8 billion by 2018. The research firm argues that the rise of mobile health has been partially encouraged by the global financial crisis, which led to a focus on finding cost efficiencies in the system in addition to improved outcomes and quality of care.

Global Data also writes that mobile health offerings “have been shown to improve patient and physician convenience, enable remote monitoring, and improve care-coordination among medical professionals, patients and public health systems.” The firm also points to a notable increase in mHealth related product development and market consolidation.

Global Data’s $8 billion figure falls short when compared to other recently published mHealth market opportunity estimates: According to PricewaterhouseCoopers, the worldwide mHealth market will grow to a revenue opportunity worth $23 billion by 2017. PwC’s report was funded by the GSM Association and published during the first quarter of this year. According to the PwC report, the European market alone will have an almost $7 billion market opportunity by 2017 — a full year before Global Data’s $8 billion worldwide prediction.

More details in Global Data’s full press release below: Keep reading>>

Fitbit data heading to your EHR soon?

By: Brian Dolan | Apr 16, 2012        

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Allscripts Wand iPad EHR

Allscripts' recently launched Wand EHR iPad app

In late 2010 MobiHealthNews reported on one of the first announced integrations of data from a patient-facing mobile health application and an electronic medical record in use at a healthcare facility: WellDoc integrated its DiabetesManager program with Allscripts’ EHR because that happened to be the system in use at WellDoc’s partner site, George Washington University Medical Center. Such integration is not without costs, of course, and in that case the US Air Force picked up the tab as part of its own research into diabetes management.

This week Allscripts CEO Glen Tullman penned a sprawling, enthusiastic column for Forbes that includes his experiences with smartphone-based, real-time video consults with physicians, the rise of connected personal health devices, and more. Tullman also included a reference to Allscripts recent work toward mobile health and EHR integration front at tail end of his post:

“As doctors begin to get compensated for keeping their patients healthy and not just for treating them when they’re sick, this kind of real-time inexpensive data will be essential. This exact scenario is already happening at UMass Memorial in Worcester, Mass., where diabetes patients upload their glucometers into an app called MyCareTeam that analyzes the data and turns it into actionable insights that are provided to physicians, nurses and diabetes educators through their Allscripts Electronic Health Record. It’s the future of health care, right before your eyes.”

Allscripts announced the collaboration with MyCareTeam last month, but Tullman hints that soon data from the connected fitness device Fitbit will find its way into EMRs. Keep reading>>

Researchers create firewall for wireless medical devices

By: Brian Dolan | Apr 16, 2012        

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Anand Raghunathan

Purdue University Professor Anand Raghunathan

Researchers working at Purdue University and Princeton University have developed a proof-of-concept device, called MedMon, that blocks hackers from hijacking or interfering with wireless medical devices, like pacemakers, insulin pumps, or brain implants. The researchers were motivated to work on the problem after discovering how easy it was for hackers to break into current wireless medical systems.

The researchers believe that hundreds of thousands of people using wireless insulin pumps or wireless-enabled pacemakers are currently vulnerable. Other devices, not yet in the market, like brain implants that manage epilepsy and “smart prosthetics” could also be hacked. Despite the potential for hacking, the researchers admit the chances that any given would be hacked is low.

The prototype MedMon (medical monitor) device acts as a firewall that prevents hackers from interfering with these devices. The team has demonstrated the system protecting a diabetes system that consists of a wireless-enabled glucose meter and insulin pump that communicate with each other via short range wireless.

“It’s an additional device that you could wear, so you wouldn’t need to change any of the existing implantable devices,” Anand Raghunathan, a Purdue professor of electrical and computer engineering said. “This could be worn as a necklace, or it could be integrated into your cell phone, for example.”

More in the press release below: Keep reading>>

Embrace, don’t fear SMS for patient convenience

By: Neil Versel | Apr 12, 2012        

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Neil_Versel_LargeThere’s a lot of talk out there about text messaging not being appropriate for many healthcare uses. The usual excuses are that SMS is not secure to healthcare standards, that you can’t really prioritize delivery of text messages and that there is no way to “escalate” texts if earlier messages aren’t acted upon.

Those are all valid points. In particular, anything involving personally identifiable, protected health information (as defined by HIPAA) certainly is not appropriate for an unencrypted text message. But let’s not completely dismiss texting in healthcare settings.

As the Montreal Gazette reported last week, several walk-in clinics in that city have started sparing patients endless waits by sending a text or an automated voice message when it’s almost their turn to see the doctor.

“The patients gain back their freedom. They don’t have to wait for four or five hours in a waiting room full of sick people,” Sara Michaels, the manager of one clinic, told the newspaper. “Instead, they can take a number, and then they can go out and do their groceries or whatever, and the system will alert them to come back,” she added.

“In a sense, it’s like coming in and asking for an appointment later in the day, something we couldn’t do before.”

The problem of long waiting times is particularly acute in the Montreal area, where, according to the Gazette, 300,000 people do not have a regular family physician. Say what you want about the government-run Canadian healthcare system that is plagued with provider shortages, but we have quite an access problem in this country, too. Keep reading>>

PositiveID’s cellular-enabled iGlucose hub now on sale

By: Brian Dolan | Apr 12, 2012        

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iglucosePositiveID announced this week that its cellular-enabled iGlucose mobile health system, which adds cellular connectivity to a handful of commercially available glucose meters, is now available for pre-order. It expects to commercially launch the device sometime during this quarter. The company also claimed to be in the process of rolling out pilot programs with health insurers and home-healthcare providers, but did not provide specifics.

In November 2011 PositiveID announced that the FDA had cleared iGlucose, which only worked with two glucose meters at the time: the LifeScan OneTouch and Nipro Diagnostic True. Now the device also works with Abbott FreeStyle and Bayer Contour devices too, according to the company. The iGlucose device transmits the data to a secure database via a cellular connection supported by AT&T in the US and Rogers in Canada.

“iGlucose eliminates the burden of keeping manual logbooks and empowers individuals with diabetes to be more engaged in the self-management of their condition,” according to a company press release. “iGlucose uses mobile technology to seamlessly communicate blood glucose readings from an individual’s data-capable glucometer to the iglucose diabetes management portal, where, with the user’s consent, glucose readings can be shared automatically with family members, caregivers and healthcare professionals via text message, email or fax.”

Last year Glooko started selling a cord that connects already available glucose meters to a user’s iPhone to transmit data to an app on the device — another way to solve the manual logbook issue. Telcare, the first cellular-enabled and integrated glucose meter, also recently became commercially available after securing an FDA clearance in August 2011. Sanofi and AgaMatrix’s iBGStar iPhone peripheral glucose meter is currently available in Europe but has yet to commercially launch in the US after securing FDA clearance late last year.

More on the imminent iGlucose launch in the press release below: Keep reading>>