Using online medical resources to diagnose our various aches and pains is just as likely to send someone rushing to the doctor in the belief they have some incurable, life-threatening disease as it is to put any fears to rest. Medical startup Scanadu, which is based at the NASA-Ames Research Center, is set to provide a set of home diagnostic tools that are designed to let users monitor their health over time and provide a better indication of whether a trip to the doc is actually necessary.
While Scanadu continues working on a tricorder-like device capable of capturing key health metrics and diagnosing a set of 15 diseases in an attempt to claim the US10 million Qualcomm Tricorder X Prize, it has just revealed its first three consumer health products that are designed to put a doctor in your pocket.
“The thermometer, introduced in the 1800s, was the last great tool to revolutionize home healthcare,” said Walter de Brouwer, founder and CEO of Scanadu. “Consumers don’t have the tools they need to monitor their health and make informed decisions about when they’re actually sick and need to see a doctor. We want to empower consumers to take control of their health and give them direct access to their personal healthfeed.”
The first device in the company’s initial product lineup is the Scanadu SCOUT, a palm-sized device designed by Yves Behar that Scanadu says will accurately read a variety of vital signs when held to the temple for a period of under 10 seconds. Data collected by the device is transmitted via Bluetooth to a smartphone, where the Scanadu app will display pulse transit time, pulse rate, electrical heart activity, temperature, heart rate variability and blood oxygenation. The data can also be transmitted to the user’s doctor. The SCOUT is expected to retail for under US$150.
Scanadu’s other two products, which also work in conjunction with Scandu’s smartphone app, are designed as low-cost, disposable diagnostic tools.
Turning a smartphone into a urine analysis reader is the ScanaFlo, which is a disposable cartridge that is designed to be sold over the counter. It will test for complications during pregnancy, preeclampisa, gestational diabetes, kidney failure and urinary tract infections. Scanadu also claims it will be the first consumer device to provide a personal “healthfeed” for the duration of a pregnancy.
Also designed as a disposable cartridge, the third and final entry in Scandu’s initial product line is the ScanaFlu. As its name suggests, the ScanFlu is designed to quickly assess cold-like symptoms, with the ability to test saliva for the early detection of Strep A, Influenza A, Influenza B, Adenovirus and RSV.
Currently, only the design of the SCOUT has been revealed, with the ScanaFlo and ScanaFlu both still at the concept design stage. However, all three devices are set to be released before the end of 2013.
Source: Scanadu
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.