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