Scanadu to shut down support for its Scout device per FDA regulation and customers are mad

Scanadu to shut down support for its Scout device per FDA regulation and customers are mad
By Sarah Buhr
Dec 13 2016
https://techcrunch.com/2016/12/13/fda-orders-scanadu-to-shut-down-support-for-its-scout-device-and-customers-are-mad/

Medical startup Scanadu informed customers today it will no longer support its Scout device starting May 15, 2017.

The reason? Though Scanadu has been working with the Food and Drug Administration to get full approval for this and other devices, it seems Scout didn’t make the cut.

Scanadu came out of the X Prize Foundation’s Qualcomm Tricorder competition, but soon broke an Indiegogo record, raising more than $1.6 million in less than a month for the Scout, a medical device that could check for heart rate, blood pressure and body temperature.

Scanadu used Scout, which could detect vitals such as temperature and upload that information to a smartphone, as a preliminary device for medical research. The device could also send collected information from an app to your doctor.
The FDA has declined to comment on why Scanadu is shutting down support for Scout, but according to Scanadu, Scout was simply an investigational device under the Scripps Institutional Review Board (IRB) approved protocol.

“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,” a Scanadu spokesperson told TechCrunch. “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.

However, customers paid anywhere from $149 on Indiegogo to $199 to use the device and the information Scout users were given at the beginning of the study conveyed Scout would continue to work after the study.

“You will be in the study for a minimum of 12 months and the study will remain open for 18 months or until FDA clearance of Scanadu Scout,” read a letter to customers. “After the 18-month survey, your continued participation in the study will be purely passive, meaning you will not be asked to do anything and only your usage data of the Scanadu Scout will continue to be collected.”

The new letter sent to Scout supporters talks about the startup’s commitment to continue bringing innovative technologies to consumers, just not with Scout.

[snip]

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