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Strong Statements from Vinod Khosla at HLTH

Posted on May 16, 2018 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

Last week I had the opportunity to attend a small piece of the new HLTH conference in Las Vegas. My time at the event was cut extremely short as I had to head to Science Camp with 80 5th graders (including my daughter), but I was able to hear the opening keynotes on Sunday. I was most interested in hearing from Vinod Khosla who I don’t always agree with, but he often causes me to look at something a little different or to see the future in a new way. As usual, that’s what he delivered on stage (Between pitches for his companies of course). Here’s a look at some of the pictures and tweets I shared from Vinod’s talk at HLTH.


Needless to say, HLTH was a big event. When you pour $5 million into an event, it better be big. Not to mention the marketing they did for the event. I’m glad to not see HLTH ads on every website I visit now. The turnout for the event seemed good. I saw a lot of social media people there that I know. I was surprised by how many young people were at the conference. Maybe the CEOs they reference in their marketing were a lot of startup CEOs.


This was an extremely powerful and thought provoking statement for me. His assertion is that instead of treating people based on their symptoms, the devices and sensors we use to monitor and measure our health will be so good that these health measurements will drive medicine and not the symptoms we experience. Chew on that concept for a while and you’ll see how it’s not that far fetched even if it is still a ways away.


I’m no expert on medical education, but this does bring up some challenging questions for medical schools. In many ways, it’s similar to what I feel about elementary school for my kids. Sure, there’s a baseline of knowledge that is helpful to understand. However, when it comes to diagnosis, treatment, etc, we’re going to have to seriously consider how we train future doctors. New skills are going to be required to effectively treat a patient. I can’t imagine most medical schools are going to be ready to adapt to this change.


I tweeted this after Vinod talked about all the various tests, labs, etc he’s getting. He sees it as research and suggests that it’s not something that other people should be doing. Vinod seems to have a similar view of health testing as Mark Cuban. Mark Cuban controversial suggested that those who can afford it should do regular blood tests. Opponents argue that it drives unnecessary procedures, unnecessary health fears, and plenty of other issues from over testing. I’ve always felt like there was a balance and it was important for Vinod and Mark to understand these possibilities as they test regularly. However, having this baseline of information could be extremely valuable in discovering what really influences our health.

Some pretty interesting things to think about. Is it very practical for a health IT professional? Probably not and that’s probably why I didn’t see any health IT professionals, CIOs, or other people like that at the HLTH conference. That’s not the goal of the conference really. It seems like there will be another HLTH in 2019. Will be interesting to see what vendors return and who doesn’t.

Of course, some people got distracted at HLTH by the wedding chapel:


Then again, maybe a HLTH Wedding might be a great outcome for some people.

Privacy Fears May Be Holding Back Digital Therapeutics Adoption

Posted on May 3, 2018 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

Consumers were already afraid that their providers might not be able to protect the privacy of their health data. Given the daily news coverage of large data breaches and since the Facebook data scandal blew up, consumers may be even less likely try out new digital health approaches.

For example, a new study by innovation consultancy Enspektos has concluded that patients may be afraid to adopt digital therapeutics options. Many fear that the data might be compromised or the technology may subject them to unwanted personal surveillance.

Without a doubt, digital therapeutics could have a great future. Possibilities include technologies such as prescription drugs with embedded sensors tracking medication compliance, as well as mobile apps that could potentially replace drugs. However, consumers’ appetite for such innovations may be diminishing as consumer fears over data privacy grow.

The research, which was done in collaboration with Savvy Cooperative, found that one-third of respondents fear that such devices will be used to track their behavior in invasive ways or that the data might be sold to a third party without the permission. As the research authors note, it’s hard to argue that the Facebook affair has ratcheted up these concerns.

Other research by Enspektos includes some related points:

  • Machine-aided diagnosis is growing as AI, wearables and data analytics are combined to predict and treat diseases
  • The deployment of end-to-end digital services is increasing as healthcare organizations work to create comprehensive platforms that embrace a wide range of conditions

It’s worth noting that It’s not just consumers who are worried about new forms of hacker intrusions. Industry CIOs have been fretting as it’s become more common for cybercriminals to attack healthcare organizations specifically. In fact, just last month Symantec identified a group known as Orangeworm that is breaking into x-ray, MRI and other medical equipment.

If groups like Orangeworm have begun to attack medical devices — something cybersecurity experts have predicted for years — we’re looking at a new phase in the battle to protect hospital devices and data. If one cybercriminal decides to focus on healthcare specifically, it’s likely that others will as well.

It’s bad enough that people are worried about the downsides of digital therapeutics. If they really knew how insecure their overall medical data could be going forward, they might be afraid to even sign in to their portal again.

IoT Cartoon – So Much Healthcare – Fun Friday

Posted on February 2, 2018 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

SAP shared a really great IoT cartoon that illustrated a wide variety of ways that our devices (and yes, everything is becoming a device) will be connecting and communicating with us. What was surprising to me when I saw it was how many of them had something to do with our health.

Obviously we still have some work to do with how our devices communicate with us. However, this was a funny look at the future of what’s being monitored and communicated to us.

AliveCor Interview – Raises $30 Million

Posted on March 22, 2017 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

When I look across the mobile health ecosystem, one of the big winners is AliveCor. They’ve done an incredible job with their company and bringing their ECG readings to a much wider audience. The news recently came out that they’d raised their Series D round of investment of $30 million. As part of that announcement, my colleague Neil Versel from Meaningful Health IT News did an interview with the COO from AliveCor, Doug Biehn. You can check out the full interview below:

I hadn’t caught up with AliveCor for a while, so it was interesting to hear how much progress the company has made. Neil does a good job covering how AliveCor has been trying to figure out the balance between a consumer solution and a provider (FDA cleared) solution.

One of my favorite comments from the video above is when Neil asks about their new AlieCor platform and Doug Biehn says, “We’ve been launching new apps in the consumer space every 6 weeks for the past year, but this is our first big entree into the medical professional market.” I love this sort of iterative development in healthcare. While AliveCor does ECG, I think they’re just getting started. I’ll be interested to see what else comes out of this company as it continues to iterate and mature.

LEVL – Measuring Fat Burning

Posted on March 9, 2017 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

I’ve been sitting on this story since CES and just hadn’t had the time to write it. Plus, it dives into some deep biology and chemistry that really isn’t my wheel house, but I think the concept is too interesting not to write about it. Plus, I think this is an illustration of the larger trend I’ve been writing about which is that sensors are arriving to measure every aspect of our body.

While at CES, I had the chance to talk with LEVL. LEVL creates a device which measures the acetone level in your breathe. Here’s the science they shared with me about why the level of acetone in your breathe matters:

Previous clinical research demonstrates a correlation between the amount of acetone detected in the breath and body fat burned, giving you a reliable indicator of fat loss. LEVL is designed to detect trace amounts of acetone in your breath when your body is burning fat. LEVL Clinical Scientist, Joe Anderson Ph.D. emphasizes the significance of breath acetone measurement as it applies to the weight loss in his review, Measuring Breath Acetone for Monitoring Fat Loss in Obesity – A Research Journal.

If you want more details of how this should work, check out this video that LEVL created:

I’ll admit that the science seems interesting, but not totally definitive. Especially when it comes to actually moving the needle on people using weight. LEVL is still early in the process of figuring out how to take the data and make it actionable for the consumer. However, the concept of being able to answer the question “Are your actions helping you burn fat?” is a very interesting take that I think could be effective for many people if it’s framed the right way.

I asked the person I met from LEVL which things influenced acetone and he said “The things you’d expect” and then listed off fatty foods, sugar, no exercise, etc. Not really shocking since we have so much experiential data that knows the impact of those things on weight. That said, I could see the LEVL data being another element that at trainer or health coach could use to help motivate a patient. In fact, personal trainers are one of their big target markets to start.

It looks like LEVL is currently only available in Seattle and they are offering a LEVLhome and a LEVLpro device. The former is obviously for home use and the later is for health and wellness professionals. The product isn’t cheap. The home version is $699 and $49/mnth and the pro version is $699 + $149/month. That includes the device, app, sensor refills and calibration gas. The pro version also includes a client dashboard, training and education, and special support.

As I mentioned at the start, this is some pretty heavy science that I’ll leave to other people with more experience. However, the concept is quite interesting and I still expect we’ll see a wave of these types of devices that measure every aspect of our health.

Fewer But Better – Connected Health at #HIMSS17

Posted on March 3, 2017 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

Since I go to so many connected health related conferences, seeing the latest in connected health at HIMSS is not really a huge deal. In most cases, I’ve already seen it somewhere else in a less hectic environment. With that said, I thought I’d see a real explosion of these devices at the conference. Certainly, there were many there, but I didn’t see the explosion that I had expected.

While there was a concentration of them in the Connected Health area, most of the rest of the show floor didn’t have many that I noticed. No doubt we each have our own unique experience at a 40,000 person and 1200 exhibitor conference. So, I’d be interested in hearing what other people’s experiences were at the event.

Even though I didn’t see an explosion of connected health devices (In fact, I may have seen fewer!), I do think that the devices that were being demonstrated are going a lot deeper and doing much more than previous years. That’s a good thing because these devices need to be medical relevant for the healthcare establishment to really care about them.

One example was a demo I saw at the DellEMC booth. They had an incredible dashboard of data that was pulling in a number of different health devices. One tracking pill that you swallow was particularly intriguing. The pill showed that the guy demoing the software had been pretty stressed that morning when the demo wasn’t working quite right. Luckily when I was there he was doing better.

Another feature of these connected health devices that hit me was how far they could reach. At the same demo with DellEMC, they had devices that could be tracked for nearly the entire HIMSS Exhibit hall (All of the Orlando Convention Center). While that’s not needed for home applications where wifi is basically ubiquitous, this is a very valuable tool to connect devices in a hospital setting.

As I mentioned, I hadn’t seen many new things, but we’re seeing the natural evolution of these connected health devices. They haven’t really broken out at HIMSS, but they are definitely getting more mature and that’s a good thing.

Noninvasive 3D Heart Mapping System

Posted on February 9, 2017 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

Last week, Medtronic got FDA approval for their CardioInsight™ Mapping Vest.

I’ll admit that many of the technical details of the CardioInsight product are well above my health knowledge, but those that are interested should go and read Heather Mack’s article on mobihealthnews to get more detail.

What I do get is that this new FDA cleared device can create a 3D map of your heart using 252 electrode sensors and doesn’t require a doctor to insert a catheter to get a cardiac map of the heart. That’s pretty impressive technology and it’s great that it’s already been FDA cleared.

While I can see how this will be extremely valuable when identifying the origin of arrhythmias, I’m interested to see what other data this device will be able to collect and the insights that will come from that data. I also love that this non-invasive approach is much better for the patient on a number of levels including not having to have to spend time and be stressed over an invasive clinical procedure.

For a while, I’ve suggested that we’re still in the very early days of health sensors. This heart mapping vest seems to be a nice step forward in that progression. I can’t see us wearing one of these in our homes, but we may be able to use it discover what insights matter and develop consumer-based sensors that you would use in the home.

What will they think of next? Actually, that’s the most exciting part of working in digital health.

Is the New Clinic, Forward, Only Reasonable for the Silicon Valley Elite?

Posted on January 19, 2017 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

A new clinic has been opened in San Francisco called Forward which is an attempt to reinvent the doctor’s office by several dozen former employees of Google, Facebook, Uber, and Palantir. On the one hand, this new clinic is an amalgamation of all the innovation that’s been happening in the digital health space. On the other hand, it seems to illustrate Silicon Valley excess and culture. Let’s take a look at each perspective.

Forward starts the patient experience with an iPad sign in that’s setup looks a lot like the Apple Store. It sounds like they’ve built all new software for their clinic, but tablet check in or other kiosk check in options have been in healthcare for quite a while. After checking in on the iPad, the patient then goes to a body scanner that identifies you using 2 fingers and then gathers your height, weight, body temperature, heart rate and the amount of oxygen in your blood. All of this data is available to doctors today, but this is a novel way to collect the data that likely saves time for patients and the clinic staff.

The exam rooms look like a really well designed exam room, but still feel like an exam room you might go to in most doctor’s offices. However, one notable feature of the exam room is a massive touch-screen display on the wall.

What makes the exam room and this touch screen unique is that the exam room listens to what’s being said in the room and pulls out information for the medical record and displays that information on the screen in real time. This sounds a lot like what I described in my Video EHR idea. The screen will also show the patient’s health history including sensor data and suggests diagnoses and treatment plans. How well it does at this is a good question, but in true Silicon Valley fashion I’m sure it’s an MVP (Minimum Viable Product) that will improve over time.

Many are touting Forward’s unique approach to Urine Sample collection, but this has been done in many other offices for years. Is this really an issue? I don’t think so. Forward also has essentially a health store as well that sells everything from wearable sensors to vitamins and supplements to skin care products. This has a kind of Apple Store feel as well. This can be a great revenue stream for clinics. Eventually you can imagine all of these items being ordered at the doctor’s office and delivered to your house or office by drone. Until then, UPS/FedEx/USPS will have to do.

As you can imagine, all of the biometric data that’s collected at check in, lab results, etc syncs up with a mobile app that the patient can use to access their health data. Looks like they have plans for genomic data as well. Forward has also committed to responding to messages from it’s members (yes, they call you members, not patients) within 1 minute day or night. I wonder if that response is a real human or an AI bot.

As I mentioned, this feels like an amalgamation of everything that’s been happening with digital health. If you’ve followed the digital health space, then you’ve seen almost all of these things done individually somewhere already. This isn’t necessarily a knock on Forward. The iPhone largely was an incorporation of a bunch of innovations that were available elsewhere. However, Apple packaged it nicely into an extremely usable package. Is that what Forward’s done here? I personally think that’s overstating things since they haven’t completely transformed the model (yet?), but it has made a high end medical office experience.

That leads to my second observation about Forward. In many ways, Forward just looks like Silicon Valley excess in the same vein as the over engineered $1500 Smart Oven. How many of the things mentioned above actually improve your care or inspire you to be healthier and how many of them are just for show?

I guess you could make the case that the whole package makes for a better experience that makes you want to go to the doctor, but that’s butting up against a massive desire we all have of not going to the doctor that’s been built into our DNA for years. Plus, the package doesn’t seem like it’s reached the nirvana of treating healthy patients, but instead is just a high end doctor visit experience.

I’m not suggesting that there’s anything wrong with creating a high end doctor visit experience. That very well could work in wealthy areas like Silicon Valley and other areas of the country like New York and LA. That very well could be a good business (although, my guess is they raised too much money for that to be their only business), but it’s not going to transform healthcare as we know it. I don’t see how Forward scales down to the lower end of the market. They should go and talk with ZDoggMD about his experience with Turntable Health which he just had to shut down. They could learn a lot from his experiences.

I’m not saying that no good will come from the Forward experience. It’s quite possible that the Forward clinic is used as an incubation lab for new ideas which the company can then commercialize and sell to the rest of the medical world at a reasonable price. Their excess could produce learnings that could benefit the rest of healthcare if they package it the right way and don’t just try to build a new health care system themselves. That would be an incredible outcome for healthcare.

I know every doctor would rejoice at the idea of a smart patient wall that listened to their interaction with the patient and did the proper documentation for them. That’s the face to face interaction for which doctors and patients now yearn. The big challenge here is that Forward doesn’t have to worry about things like insurance reimbursement, meaningful use, and MACRA. So, will their technology apply to the rest of healthcare? Or does it just enable the high end unlimited primary care model that they’re executing today?

Also, Forward is only working on primary care, wellness, and men’s and women’s health. That still leaves specialists in the regular insurance controlled world (Yes, you still need insurance and the $149/month membership to Forward). Can high quality primary care change healthcare? I think it could, but it’s going to take a shift in mindset (payers, employers, patients, doctors) by many for it to happen.

I know another medical practice in San Francisco that built their practice on the back of cash patients who got a great, fast customer experience. Employers in San Francisco were happy to pay cash for the visit because they knew their employee would be off work at the doctor’s office for less time then traditional healthcare paid for largely by insurance. The cash cost of a visit was much less than having that employee away from work. San Francisco is a unique culture and so that worked for this medical practice and Forward could work in San Francisco as well. I just don’t see the path for them to scale the clinic model across the country. I hope they don’t try, but instead focus on spreading their innovations across the country. If all that fails, at least the Silicon Valley elite now have an opportunity to network with other Silicon Valley elite at the doctor’s office.

Healthcare Is Going to Benefit from the Confluence of Consumer Technologies

Posted on December 28, 2016 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

Next week is the annual CES conference in Las Vegas. It’s a unique event that brings together 170,000 people across 4 of the largest conference venues in the world. It’s enormous and a little hard to process.

Having attended for the last ~11 years, it’s been amazing to see the pace of progress with so many technologies. Remember that it’s only been about 9 years since the iPhone was launched. While smartphones and tablets have gotten so much better over this time period a whole slew of other consumer technologies have as well.

Looking forward to CES, it’s amazing to see the development of things like: 3D Printing, Virtual Reality, Augmented reality, IoT (Internet of Things…or as I like to call it Smart Everything), voice recognition, AI, robotics, sensors, etc etc etc. It’s an exciting time to be in an industry where so many things are developing so quickly.

Maybe I’m skewed because I’m a blogger in healthcare, but it’s really amazing how healthcare sits at the confluence of so many of these technologies. The overlap that’s going to happen between augmented reality, 3D printing, AI, sensors and new things we barely understand is going to be extraordinary.

I recently saw a 3D printing conference for healthcare. While 3D printing is very exciting for healthcare, it wouldn’t be nearly as exciting if we didn’t have all of the other innovations in cameras, storage, data sharing, virtual reality, etc. We needed evolutions and innovations in all of these spaces for the other technologies to really work well.

I’ve often said that the most interesting things in healthcare happen at the intersections. I think that’s particularly true in the digital health space. As I head to CES, I’ll be watching for this type of crossover of technologies. I think this year we’re going to see a lot of companies utilizing multiple technologies in ways we’d never seen previously.

Scanadu to Shut Down Scout Medical Device Per FDA Regulation

Posted on December 14, 2016 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

The famous Qualcomm Tricorder prize winner and IndieGogo crowdfunding success, Scanadu, has just hit some major bumps in the road. In fact, you might say they lost their engine completely. After winning the X Prize foundation’s tricorder competition, they went on to raise more than $1.6 million on IndieGogo from 8509 backers.

After shipping the product, Techcrunch just broke the news that Scanadu was now planning to disable the Scout’s functionality. Yes, that’s right. People paid $149-269 for the Scanadu Scout and now Scanadu is going to brick all of the devices. Here’s their official comment to Techcrunch:

“From the beginning of the campaign, this was an investigational device that was part of a study which has now reached its endpoint with data collection for the study ending in November 2016. FDA regulations require that all investigational studies be brought to closure and their respective devices be deactivated. As a result, we will deactivate the Scanadu Scout® devices by May 15, 2017.

Interestingly, the Scanadu website, Twitter, Facebook, etc are all quiet. In fact, most of them have been quiet since April. What hasn’t been quiet is customers anger towards Scanadu. That’s true on social media, but also in the IndieGogo comment section where Scanadu had raised $1.6 million.

You can imagine people’s anger. Their expensive device will now be useless. As one commenter pointed out, someone bought 100 of them. That person will now essentially have 100 expensive bricks. In the comments, people are calling for a class action lawsuit, refunds from IndieGogo and outrage at the company doing this to them. The most salient point is that it’s hard to imagine anyone ever buying a product from Scanadu again after something like this occurs. One commenter suggested the following:

The consent doc also says: “If you have any questions about your rights, call the Scripps Office for the Protection of Research Subjects at (858) 652-5500. ” [Note: Scripps is performing the study based on the Scanadu data.]

Some people in the comments are even commenting that there’s no such FDA regulation. I’m not an expert on FDA regulation, but my gut tells me there’s more to this story than we know today. I could easily see how there could be an FDA regulation that required a company to shut down devices that made claims they couldn’t achieve and therefore put people’s health in danger. I’m not sure if this is what’s happening with Scanadu, but when there’s smoke there’s usually fire.

I think we all loved the romanticized idea of a medical tricorder. Haven’t we all wanted one since we first saw it portrayed on Star Trek? Scanadu was trying to make it a reality, but it seems their efforts have fallen flat. This is a good warning to everyone else out there. FDA compliance is no joke. Even winning an X Prize, a successful crowd funding campaign, and raising $35 million in funding doesn’t guarantee success.

Innovation in healthcare is hard!