Independence Blue Cross invests in chronic care app developer CareCam

By: Aditi Pai | Jan 20, 2015        

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CareCam Health SystemsWest Conshohocken, Pennsylvania-based chronic care app developer CareCam Health Systems received a strategic investment from Independence Blue Cross Center for Health Care Innovation. CareCam has already raised at least $12.4 million to date.

CareCam raised $2.4 million late last year, according to a filing with the SEC in November. Given the timing, it is likely the Independence Blue Cross investment made up all or part of that round, which the filing notes had one investor. We’ll update with more information once the company responds to our request for additional details.

Update: CareCam confirmed to MobiHealthNews that the $2.4 million funding in November was from Independence Blue Cross.

Independence Blue Cross launched its Center for Health Care Innovation in February 2014. The Center for Health Care Innovation’s initiatives include investing in startups and partnering with universities.

Independence Blue Cross plans to work with CareCam to develop programs that aim to improve the care of people with chronic health conditions. CareCam’s initial rollout with Independence is focused on supporting members with diabetes and asthma.  Keep reading>>

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Where are CES 2014 digital health devices now?

By: Aditi Pai | Jan 20, 2015        

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CES 2015 ended earlier this month, and like last year, a significant portion of the show floor was dominated by digital health products. Companies showed off a number of activity trackers, sleep devices, an oral health tracker, connected weight scales, and a few adhesive temperature devices. And also like last year, most of the products MobiHealthNews covered were demos, prototypes, and concepts that the companies said would be available for pre sale sometime this year.

But, of course, companies that demo products at CES often do not launch these offerings on schedule or sometimes at all. So, MobiHealthNews took a look at our round up of digital health device announcements during CES 2014 to see where these products are now.

We’ve separated the devices into three categories — those that haven’t launched, those that launched but at a different time or price point than initially announced, and those that launched as scheduled. First off, there were a handful of startups that have not brought their products to market yet.

iHealth’s three new devices

iHealth's Wearable ECG

iHealth’s Wearable ECG

iHealth Lab, a subsidiary of Chinese medical device company Andon Health, revealed three new smartphone-enabled, wearable health devices at CES: a blood pressure monitoring vest, an ambulatory ECG device that (presumably) sticks to the wearer’s bare chest, and a wristworn pulse oximeter device. The company said at the time that none the devices have FDA clearance. If FDA clearances were secured on time, the company expected the three devices to ship in the second half of 2014. Keep reading>>

Samsung leads EarlySense’s $20M round, plans to bring contactless bed sensor to consumers

By: Jonah Comstock | Jan 20, 2015        

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chairEarlySense, an Israeli company which makes a passive and contactless bedside monitor that continuously measures respiration rate, heart rate, and motion, has raised $20 million, with $10 million constituting a strategic investment from Samsung. Welch Allyn, which licenses EarlySense’s sensor, also contributed, as did other existing investors Pitango Venture Capital, JK&B, Proseed and Noaber.

“We developed technology that monitors patients in hospitals and longterm care institutions and helps keep the patients safer, keeps them at the hospital shorter, reduces cost of care and increases safety and efficiency of care,” CEO Avner Halperin told MobiHealthNews. “We want to respond to increased demand in the market and increase our presence in this field. We’re raising funding for that purpose, and the second purpose is taking our technology and bringing it into the exciting world of digital health and wellness in the home and doing that through major partners. One of these obviously will be Samsung, who’s also investing in this round.”

As we reported in our CES news roundup, Samsung consumer products CEO BK Yoon talked up EarlySense from the stage at his CES keynote, citing it as an example of a product Samsung wants to move from the clinical space into the consumer space. Keep reading>>

FDA wellness clarifications helpful, accessory proposal is just a start

By: Brian Dolan | Jan 20, 2015        

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Brad

Bradley Merrill Thompson

At the end of last week the FDA posted two draft guidance documents related to digital health. One focused on clarifying the line (PDF) between a general wellness device or app and a regulated medical device. The other intended to help clarify when an “accessory” device (PDF) to a regulated medical device, like a companion smartphone app, for example, would also fall under the agency’s purview and be regulated as a medical device.

The first draft guidance document was fairly straight forward — we summarized it here.

Bradley Merrill Thompson, who has written extensively about mobile health regulation for MobiHealthNews over the years, sent us his initial analysis of the documents. Thompson recently served on the FDASIA workgroup, which suggested the FDA include many of the clarifications it ended up publishing in the draft guidance on wellness devices. Here are a few of the things Thompson and his colleagues asked of the FDA, and how they delivered:

We need rules not just examples: “FDA responded by including clear rules on page 3 and 4 of the draft guidance. FDA also included a very helpful algorithm on page eight of the draft guidance. I love the algorithm.”  Keep reading>>

FDA clarifies the line between wellness and regulated medical devices

By: Brian Dolan | Jan 16, 2015        

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Fitbit SurgeAs promised in its FDASIA report, the FDA has published a draft guidance document that aims to help those creating wellness devices and apps to better understand when their product (or their marketing claims) crosses over into regulated medical device territory. As always the agency is seeking comment from the industry and the public on their new draft guidance for the next 90 days.

“A general wellness product, for the purposes of this guidance, has (1) an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition,” the guidance explains.

“Where it is well understood” is an important turn of phrase here. When does a particular wellness activity’s contribution to the prevention of a specific disease or condition become “well understood”? That may be up to the lawyers to decide, but when it does, wellness device and app makers can use it in the marketing materials.

The document goes on to outline two different categories for general wellness devices that fall outside of FDA regulation.  Keep reading>>

PwC predicts “DIY Healthcare” will be the top trend of 2015

By: Jonah Comstock | Jan 15, 2015        

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“Do-it-yourself healthcare”, including mobile apps and consumer medical devices, is set to be the top healthcare trend of 2015, according to research and consulting firm PricewaterhouseCoopers. PwC announced its top 10 predicted healthcare trends of 2015 in a webinar promoting their new report, and their top three are mobile health-related trends, with mobile and digital playing a role in several more.

“For the first time really we’re discovering physicians are expressing much more openness and willingness to consider information about their patients coming from DIY devices,” Ceci Connolly, Leader of PwC’s Health Research Institute, said during the webinar.

PwC

Connolly specifically mentioned devices and apps that can monitor vital signs, analyze blood and urine, and track medication adherence. She said that the combination of technological maturity, consumer eagerness to use apps and devices, and physician willingness to work with the data (as gleaned from physician and patient surveys conducted for the report) all point to home health care as a major trend. The survey found that a third of consumers said they would use a home urinalysis device and more than half of physicians said they would use data from such a device to prescribe medication or decide whether a patient should be seen. Keep reading>>