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"First medical tricorder" seeks crowd-funding ahead of FDA approval

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May 27, 2013

Scanadu has turned to crowdfunding website Indiegogo to bring what it calls 'the first med...

Scanadu has turned to crowdfunding website Indiegogo to bring what it calls 'the first medical tricorder,' its Scout diagnostic device, to market

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Scanadu has turned to crowd-funding website Indiegogo to bring what it calls "the first medical tricorder," its Scout diagnostic device, to market. Though expected to ship to home users in March 2014, Scanadu highlights that until the Scout is approved by the FDA, it should not be thought of as a medical device. Instead, backers are described as testers who will help to gather the data to gain that approval.

To recap, the Scanadu Scout is a small disk you place against your forehead. After 10 seconds, a host of information about your current state of wellbeing is displayed on your smartphone screen. Scanadu claims the Scout can monitor heart rate, both skin and core body temperature, oximetry (or hemoglobin saturation), rate of respiration, blood pressure, the heart's electrical activity (via ECG), and "emotional stress."

Clearly the smartphone display will require a downloadable app, which Scanadu says will be available for both Android and iOS devices, with support for Bluetooth 4.0. From empty, the battery can be charged in under an hour through its Micro-USB port. If used a handful of times per day, Scanadu says the charge should last for around a week.

Initially launching as a "research tool," Scout will not make any disease diagnoses but will collect and store data. "We are creating a medical-grade device, which is not yet fully accurate and not FDA-approved," Scanadu writes on its Indiegogo campaign page. "Hence this is not a medical device. Via this campaign, you may contribute and your input may affect the final design and characteristics of this revolutionary tool."

Backers of the Scout can opt into clinical trials which Scanadu claims will collect the necessary data to submit an application to launch the product commercially. In the meantime, Scanadu highlights that the Scout "makes no medical claims."

Scanadu Scout breezed past its US$100,000 target within hours of launching, and has raised $430,000 with 26 days to go. A Scout can be reserved for a pledge of $199. Though Scanadu has been very open as to the status of the Scout, one wonders if turning to crowd-funding after FDA approval might have been a better deal for consumers. Times, they are a-changing.

Sources: Scanadu, Indiegogo

About the Author
James Holloway James lives in East London where he punctuates endless tea drinking with freelance writing and meteorological angst. Unlocking Every Extend Extra Extreme’s “Master of Extreme” achievement was the fourth proudest moment of his life.   All articles by James Holloway
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5 Comments

I think this is good because it will give them enough money and time to develop a better product. Then they can launch anouther one maybe on kickstarter next time where they release the fully developed due to funding product.

Ben Tumaru O'Brien
27th May, 2013 @ 02:44 pm PDT

Do they plan to steal our medical data? Well, thanks but no thanks.

Kris Lee
27th May, 2013 @ 02:54 pm PDT

Whining about the first version limitations of just about any significant technologically challenging product to emerge over the last 30-40 years will not contribute any value and in very-soon-to-arrive hindsight will be seen as quaint, at best. The first first PCs were dogs, and for the Altair 8000, most never actually ran or were finished from kits and in any event there was not "software" to run on them. Within a few years the term "software" had been coined and almost explosively evolved and spread everywhere! The first digital camera cost $30K and was clunky. Now, not only are digital cameras cheep & great, but Kodak is all but completely out of the camera business, soon film will follow.

So also will this new field evolve to the point that these devices will be ubiquitous, inexpensive, and great. This is just one part of a moving leading edge of innovation that will deliver high quality analysis to a users hands pretty much anywhere and for pretty much any application with near instantaneous conferencing & communication as easily added features.

StWils
28th May, 2013 @ 10:06 am PDT

This is a clever idea. Combined with mobile communications this could be a invaluable tool for first aiders especially in remote areas. Diagnostic quality information could be transmitted directly to medical aid who can then provide instructions for a first aid provider.

Ian McIntosh
28th May, 2013 @ 09:00 pm PDT

FDA regulations explicitly prohibit marketing an investigational device prior to FDA approval for commercial distribution:

21 C.F.R. Sec. 812.7 Prohibition of promotion and other practices.

A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:

(a) Promote or test market an investigational device, until after FDA has approved the device for commercial distribution.

“It’s sold as a research device for investigational use. Everyone who buys it is essentially a researcher in that project,” De Brouwer told MobiHealthNews in May of 2013 at the beginning of the Indiegogo campaign. Key words there: SOLD, EVERYONE, and BUYS. Walter De Brouwer himself characterized the Indiegogo campaign as selling the Scout as an "investigational device" to Indiegogo buyers, which is explicitly prohibited by the FDA.

That's all somewhat academic at this point as Scanadu is more than 6 months past the date it promised to deliver those "investigational" devices to Indiegogo purchasers. The excuses coming from Scanadu for the delays have been pretty lame, and are frankly in direct contradiction to De Brouwer's claims in May of last year when he stated in MobileHealthNews that “The device has seen 18 iterations, the industrial design is ready, the algorithms are in place, the manufacturer is secured, the FDA audit trails are operational. For Scanadu this is just the end of the beginning. We did Indiegogo when we were over-ready.” That sure seems like one big fat fib right about now.

The only thing lamer than De Brouwer's excuses is the failure of media outlets like gizmag to follow up on the hype they helped build for this debacle.

Chuck Juhl
9th October, 2014 @ 05:51 pm PDT
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