We have had a huge response to the questionnaire in our latest update. THANK YOU!
The Scanadu Team
We hope everyone had a great Thanksgiving. We know we did, as we have great news. The first Scanadu Scout devices are alive and working, currently gathering physiologic data. The data shown below is of an ECG and a PPG signal collected with the Scanadu Scout device. After getting rid of all interferences and other issues, we finally tamed the board, as it is never easy to obtain stable and very high quality data from such a compact instrument with multiple sensors. This quality will tame accuracy.
We have begun collecting data from everyone in our office in order to qualify the data, use it, and test and verify our algorithms before implementing an automated scan procedure.
We have gone through some development work on the PCB where we encountered signal integrity issues due to large current fluctuations. This issue is now solved and we are in the process of getting our first batch of assembled PCBs from our contract manufacturer for testing purposes. These new assembled boards will be here next week, and then we will be able to assemble more working units and start our verification and validation tests.
We are also very excited that we have finalized the 3D design, and the tooling for our injection molded parts will begin very shortly. This has been quite an accomplishment since our design makes for a very complicated tool. However, we pushed to get this done because we care about the quality of our product and we want to deliver something that not only functions correctly, but is also beautiful.
The software is our next challenge and bits and pieces will be shown to you shortly. We have spent a lot of time and hard work on the functionality and the design of our user interface and we hope to show you the first sections of the up and running App soon.
In order for us to get to know our users better and make sure everything is addressed we hope you can take 5 min of your time to help us and fill out this questionnaire.
We know you are still cheering us on and we want to ensure you that we are all very focused here at Scanadu.
We wish you all a very Happy Holiday!!!!
The Scanadu Team
We're very excited to share several updates with you today and talk about where we are in the FDA process.
As you know we've signed a deal with Sparqtron to manufacture in the US and are on track for the first delivery of the Scanadu Scout™ in March 2014.
Once you receive your devices (not be medical-grade yet), the first step in the FDA process is an usability study that you'll have the chance to opt-in to. No physiological data will be taken,it is the usage, the ease-of-use, and how you interact with the device that will be important at this stage.
We encourage you to opt-in do so as the information you provide will go towards final development of the product and be a first and very important component towards our FDA filing. Following the usability study, you will again have the option to join clinical trials for Scanadu Scout™.
There will be several clinical trials that run in parallel and we’re excited today to announce we’ll be collaborating with the Scripps Translational Science Institute (STSI) to coordinate and execute the trials.
From there, we will submit the paperwork and await for a response from the FDA. We hope the process will take about 8-10 months, however that timing is dependent on feedback from the FDA.
As you know, the approval of the medical community is imperative as we look to bring Scanadu Scout™ to a broad market. To that end, we have also set up a Medical Advisory Board to facilitate information sharing across the medical, regulatory and research fields.
These advisors all have a stake in advancing consumer healthcare. Their background includes practicing doctors, professors, entrepreneurs, and former FDA and DARPA officials from all over the country. You can see a full list on our website.
Lastly, Scanadu has raised $10.5 million in Series A funding, led by Relay Ventures with participation from Tony Hsieh, founder of Zappos, and Jerry Yang, co-founder of Yahoo. These investors have a track record of building disruptive companies of great value in the mobile, cloud, consumer and healthcare industries.
This funding will be used to support Scanadu’s go-to market strategy and manufacturing, continue its path to FDA approval and add talent to the team.
Thank you all for your continued support.
The Scanadu Team
Full press release here
Halloween has passed, but Thanksgiving and Christmas have yet to come which means we have a lot of work to do before the holidays. Currently we have received all of our plastic enclosures so we are beginning to assemble functional prototypes that can collect data from the various sensors on the device. We will use this data to verify the hardware and mechanical design and make any necessary changes as well as use it for algorithm verification and implementation. This will lead to extensive internal testing of the device and algorithms on many physiologically different people and in various environments.
The software is coming along and plans to ramp up development in the coming month. Currently we have developed our first prototype application that will be used for internal testing.
We would like to again thank everyone for contributing to our campaign and we want to share that the Citizen Doctor Perk has been enjoyed this week at Futuremed at the Hotel Del Coronado in San Diego http://futuremed2020.com/. Our CMO Alan Greene was there making sure that the Citizen Doctors were being well taken care of.
We know everyone is anxiously waiting and that March cannot come soon enough, but we are working hard making sure all the pieces to the puzzle (hardware, firmware, software, algorithms, testing, manufacturing and assembly, packaging, FDA, etc...) all fit together before March. We very much appreciate everyone's comments and contributions and look forward to our next update...
PS: our next update will be next week, we have a special announcement. Stay tuned!
The Scanadu Team
Where is my Scanadu Scout™?
It’s been roughly 2 months since the end of our crowdfunding campaign & you all are probably very anxious & wondering “Where is my Scanadu Scout™”? We assure you we have been working very hard to get it to you & are still on schedule to ship in March 2014! Right now the Scanadu Scout™ is in Moffett Field, CA (right in the heart of Silicon Valley) being developed by a dynamic & motivated team, but soon it will be manufactured right here in California.
We are very happy to announce that our manufacturer is the Sparqtron Corporation (below) & that we signed a contract with them earlier this week. Sparqtron is an ISO 9001 & ISO 13485 certified electronics manufacturer here in Fremont, CA. Where most companies need to get on a plane & fly to China or Taiwan (~6257 miles, ~13 hours) to see their production floor ours is only 22 minutes (18.8 miles) away from our labs in Moffett Field (above).For us proximity was a high on our priority list.
We have been quiet lately, it is true. Up to this point we have not shared much because, simply put, we couldn’t. We have spent a lot of time ramping up our quality management system & design controls to comply with the current regulations & design control standards. Here at Scanadu we strongly believe that consumers have the right to record their health data & that they are entitled to have accurate (regulated) readings. Therefore we are actively seeking government regulation as we want to adhere to the highest standards.What are we doing now? We are ready to start building prototypes. Our PCBs have arrived, been populated & debugged. Our programming Jig has been setup & we have been able to program & communicate with the microcontroller, as well as gather various sensor data. Our first plastics & electrodes should arrive within the next two weeks & then we can assemble our first batch of internal prototypes. In order to build this device we must design it in phases according to our Quality Control Procedures. We have officially passed our Phase 1 internal design, which means that the iOS & Android prototype apps are now being developed as well as the testing & validation of our internal prototypes.
A drum, a drum, Scanadu Scout ™ does come.
In the weeks to come we will have more to share, but in the meantime we will continue to strive for excellence & push the boundaries of innovation. Thank you all for your unending support.
The Scanadu Team