First mobile medical app to get CE Mark in UK

By: Brian Dolan | Jan 9, 2012        

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Mersey BurnsWhile AirStrip just announced that it had secured a CE Mark for its suite of mobile medical applications last week, it may have not been the very first medical app to secure a CE Mark and be publicly available in the UK market. Another app, created in cooperation with a team of UK-based plastic surgeons, apparently carries that distinction.

According to D4, a non-profit organization in the UK that equips physicians and nurses with communications devices, the very first mobile medical app to be classified as a medical device in the UK recently registered as a Class I medical device with that country’s Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA recognizes the EU’s Medical Device Directive’s classification system, which makes use of the CE Mark to designates a device is registered and in compliance with the regulatory system.

“It is understood that to date only one app that is publically available for download has been registered as a medical device with the MHRA in the UK,” D4 writes in a new report focused on the regulation of mobile medical apps in the UK.

The app is called Mersey Burns and it’s currently available for all iOS devices. The Mersey Plastic Surgery Unit helped to develop the app, which aims to help doctors more easily calculate the percentage of a patient’s body surface area that is burned and, in turn, to better calculate the amount of fluid to be administered in the 24-hour period that follows the burn injury. A small study found that those using the app had less variance among estimates for total body surface area that was affected by the burn, while those using paper based assessment tools had greater variance.

D4 included a short quote from the MHRA that provides some insight into the agency’s thinking around the regulation of medical apps: “Only after a product meets the definition of a medical device does it get classified according to risk, the risk classification then determines the compliance requirements. There is clearly a full range of application from the simple non-clinical to potentially complex ones for medical use,” the agency told D4. “As an example, if the application is intended to carry out further calculations, enhancements or interpretations of entered/captured patient data, we consider that it will be a Medical Device. If it carries out complex calculations, which replaces the clinician’s own calculation and which will therefore be relied upon, then it will certainly be considered a Medical Device.”

While the report is largely positioned as a UK-focused study, its recommendations may have wider appeal. D4 explains: “Within the UK, the MHRA is responsible as the Competent Authority under the Medical Device Directive, and provides guidance to device manufacturers. However at present there is no central European register of registered medical devices. Each Competent Authority manages its own register, and a manufacturer needs only to register in one member state to place its device on the market across the EU.”

When it comes to the US market: MobiHealthNews broke the news last July that the FDA had published a set of draft guidelines for how it suggested it might regulate mobile medical apps moving forward. Following a 90-day comment period that ended last fall, the FDA is now working to publish a final set of guidelines sometime this year. AirStrip’s OB app was the first iPhone medical app to secure FDA clearance in the US.

Be sure to read the full UK-focused D4 report for free here (PDF). More in D4’s press release below: Keep reading>>

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Basis previews its health dashboard at CES

By: Chris Gullo | Jan 9, 2012        

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basisAt CES this week Basis previewed its online portal, a dashboard for its upcoming Basis B1 band wrist-worn device. The dashboard displays the information collected by the device, including calories burned, steps taken, and hours slept, which it also rolls into a number of “points” for an overall index number (out of 100).

In a new demo video posted just before CES kicked off this week, Basis CEO Jef Holove explains that the device uses five different sensors to collect data about the user’s activity, environment, and how his body responds to those activities. The data is then uploaded to a cloud service where it is analyzed and “then told to me in everyday language — things that I could understand — about how to live better,” Holove said.

At the top of the dashboard are four big data points for calories burned, steps taken, hours slept, and overall points. Each of these includes a simple bar graph to show how close to the goal the user is at that time. Underneath those numbers is a bar graph of heart rate readings taken by the device throughout the day. Beneath that bar graph is a timeline of discreet events and activities that the device automatically detected — physical activity, sleep, etc. Those events include specific calories burned for that amount of time, too.

“Beyond those high level metrics, the system will be able to publish to you interesting insights about your day,” Holove says in the video.

While the device is obviously mobile, it’s not wireless. The data is uploaded to the cloud via the user’s computer — the B1 Band plugs into the user’s computer via USB. The company has promised future Bluetooth support.

The Basis B1 Band measures the wearer’s heart rate, temperature, and galvanic skin response via five embedded sensors. The company plans to allow third party developers to build apps that work with the device. It is expected to retail for $199 and become available sometime later this year.

Basis touts the device as comfortable and unobtrusive enough to be worn 24/7.

In an interview with MobiHealthNews last year, Holove said that most other heart rate tracking devices require chest straps, which are uncomfortable and cumbersome. Other fitness devices that may be more comfortable to wear offer a smaller subset of sensors than the array Basis has put together, he said. “We are [building] a much richer data set,” Holove told MobiHealthNews at the time.

Basis’ advisory board includes an executive at Facebook as well as the co-founders of RedOctane, co-creators of the Guitar Hero series. For six years Basis was known as PulseTracer, but the company changed names last year in anticipation of a commercial rollout. The company closed a $9 million first round of funding last March.

Read the press release below.

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Tinke, an iPhone dongle pulse oximetry device

By: Chris Gullo | Jan 9, 2012        

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TinkeSingapore-based Zensorium unveiled Tinke, an iPhone peripheral pulse oximeter device, at CES (Consumer Electronics Show) this week. Tinke is a compact device that measures blood oxygen levels, respiratory rate, and heart rate. It connects to iOS devices via the Apple device’s dock connector.

Zensorium told Forbes that the device will cost about $100 and should be available for iPhone users in about six months time. Versions compatible with other smartphones will follow shortly thereafter, a company rep told Forbes on-site at CES.

Here’s how it works: Users place a finger onto the dongle’s camera lens, which analyzes the blood vessels on their finger tip via infrared and light beams. A companion app developed by Zensorium then displays the user’s collected data within about 45 seconds. The user needs to keep their finger on the device for about that long without moving it. (Traditional pulse oximeter device clip on to a user’s fingertip to make this process a little easier.)

The Tinke app also provides an index score, called the Vita Index, every time a measurement is taken. Users can share their number, which maxes out at 99, with friends and family on a social network created specifically for the app. In addition, they can anonymously compare their Vita Index to other users in the same demographic.

“Mobile healthcare has steadily grown during the past two years and is at the stage where communication devices, pervasive sensing technologies, social networks and data analytics have arrived at a desired condition to realize a technological revolution,” Zensorium states on its website. “Tinke [is] a combination of conscientious design and technologies for you.”

While pulse ox devices are generally considered more appropriate for health care use cases, the Zensorium rep told Forbes that the company is targeting any and all health enthusiasts between the ages of 18 and 65 years old.

In January of last year, Nonin announced a wrist worn Bluetooth-enabled pulse oximeter that connected to smartphones. The device launched last October.

For more details, watch the Forbes demo of Tinke in this YouTube video.

BodyMedia to offer disposable health tracking patch

By: Brian Dolan | Jan 9, 2012        

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BodyMedia PatchAt CES (the Consumer Electronics Show) in Las Vegas, BodyMedia announced plans to offer a disposable, peel-and-stick, biometric patch developed in conjunction with medical device company Avery Dennison. The companies expect the device to be used in preliminary evaluations for weight management. (Notably, BodyMedia has an existing relationship with Jenny Craig, however, the weight loss program was not specifically mentioned in the most recent announcement.)

The patch, which is meant to be worn for up to seven days, makes use of BodyMedia’s array of sensors to track calorie burn, steps taken, activity levels, sleep patterns and more. BodyMedia says it collects more than 5,000 data points each minute. The wearable sensor leverages Avery’s proprietary Metria Wearable Sensor Technology, which is purports to be “skin-friendly”. BodyMedia’s other tracking devices are typically worn around the user’s upper arm. BodyMedia has been making such devices since 2001.

The new patch is meant to be worn on the back of the user’s left tricep, according to BodyMedia. The company expects the placement to provide “an inconspicuous solution similar to a large bandage with no wires required to transmit data.” Interestingly, competitor Basis seems to be taking an opposite approach. It wants its wrist worn health tracking device to be conspicuous as a symbol of wellness.

In the future, BodyMedia expects the patch to be used in corporate wellness programs, remote elder care and safety, and monitoring of vital signs for a variety of health conditions.

Avery’s Metria technology is based on the wearable sensor technology developed by Proteus Biomedical, which is, among other things, creating an intelligent medicine platform that can detect when a user ingests her medication. Proteus secured a patent for the technology last year. Proteus describes its technology as the “most wearable, sensor enabled and low cost sensor patch on the market”. (Updated: Originally this article incorrectly stated that Proteus licensed the technology from Avery — it is, in fact, the other way around as now stated above.)

More on the patch from BodyMedia in the press release below: Keep reading>>

Health apps already a bigger market than remote monitoring

By: Chris Gullo | Jan 6, 2012        

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iTriage, a popular medical app

iTriage, a popular medical app

According to a recent report from Frost & Sullivan, in 2015 the market for mobile health applications will be about $100 million bigger than the market for remote patient monitoring. Frost estimates that mobile health apps will reach $392 million in 2015, while remote patient monitoring will hit $294.9 million. Frost estimates that mobile health apps earned revenues in 2010 of $230 million, a higher than expected total. Remote patient monitoring generated $126.8 million in revenues.

Despite this positive industry growth, the firm’s report predicts significant challenges ahead for those working on health apps, including regulatory issues, privacy and security concerns, and consumer awareness.

Frost & Sullivan’s remote monitoring report finds that the emergence of consumer-focused monitoring products, compared to traditional telemedicine, to be a major factor in the industry’s growth. According to the report, remote monitoring has had a double digit growth rate over the past decade, but hasn’t yet reached its “billion dollar potential”. Current business models have “limited potential” in the upcoming market, Frost states.

Other analyst firms have recently published similar findings that line up with Frost & Sullivan’s predictions. A report by ABI Research released last November predicted that the market for health and fitness apps will cross $400 million in 2016. ABI believes the rise of apps for connected wearable fitness devices will be a primary factor in the industry’s growth (it predicted 80 million such sensors by 2016). ABI also predicted that there will be more than 1 billion annual health-related app downloads by the year 2016.

recent report from Berg Insight found that approximately 2.2 million patients globally used a home-based remote monitoring device as of the end of 2011. However, the metric only accounts for devices that use fixed wireless, cellular, and fixed line connections; devices that connected via smartphones or PCs were not included in the statistic. In addition, the number of home health monitoring devices in use with embedded cellular connectivity increased from 420,000 in 2010 to about 570,000 in 2011, and is expected to hit 2.47 million in 2016.

“Today, we are seeing the tip of the iceberg in the U.S. mHealth market’s potential,” stated Frost & Sullivan Senior Industry Analyst Zachary Bujnoch in a press release. “Despite the hype, mobile apps are the single-biggest digital channel since the ‘90s and the Web.”

”Over buildup and misrepresentation have made [the remote monitoring market] confusing and complicated,” added Bujnoch. “However, significant revenue and outcomes remain for those who can sift through fact and fiction.”

Read the press release below. Keep reading>>

Merck to invest upwards of $17M in Skyscape

By: Brian Dolan | Jan 5, 2012        

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Tomorrow NetworksPhysicians Interactive, which offers the popular professional medical app Skyscape, announced this week that Merck will invest up to $17 million in the company via its Global Health Innovation Fund (GHIF). Initially, the financing includes $8.5 million, but depending on whether the company meets certain milestones, Merck’s GHIF could bump the investment up another $8.5 million for a total of $17 million.

The funds will be used to grow “four key products” as well as other initiatives. Among the company’s key products and initiatives is the Skyscape app itself and a recently launched mobile advertising network, Tomorrow Networks.

Skyscape is a mobile medical content publisher whose main app offering, Skyscape Medical Resources, is a clinical decision support tool similar to Epocrates. Physicians Interactive, a digital marketing firm that targets doctors and other health workers via a number of mobile and web-based services, bought Skyscape in 2009. It now accounts for about 90 percent of its Healthcare Professionals Division. (MobiHealthNews’ own Neil Versel spoke to Healthcare Professional Division president Brett Miller last year about Skyscape’s storied 12 year history in the mobile healthcare space).

Last year, the company partnered with Remedy Systems to launch a mobile advertising network, Tomorrow Networks, that serves ads specifically targeted to healthcare providers. The network is also testing health-related ads targeting consumers. The network places ads in smartphone medical apps — it launched with some 54 different apps already onboard.

“This investment will allow us to further expand our internal product development and customer solutions, as well as explore new markets and additional customer segments,” stated Donato Tramuto, CEO and vice chairman of Physicians Interactive Holdings, in a press release.

As part of the deal, Merck’s Global Health Innovation Fund will appoint one of its executives to join Physicians Interactive’s board.

Read the press release below. Keep reading>>