A few notable posts pertaining to mobile medical applications came through my Twitter feed / Inbox recently, so I wanted to share!
The latest mobile medical application news on the industry's collective mind is the issuance of an "It has come to our attention..." letter sent to Biosense Technologies in India, essentially questioning why Biosense has not obtained 510(k) clearance for their uChek mobile application. The device is a mobile medical application for phones that takes a picture of urinalysis strips and compares the color against a standard to make a determination about the status of a patients urine. It also includes a box that controls external light to ensure better quality of the results. From a "fan" standpoint, it's an awesome device and technology. You can see it demo-ed during the TED talk given by the company's CEO.
With the recent announcement of 510(k) clearance of a retinal examining attachment and companion app can we now declare the outcry against the FDA finished?
I sat down tonight, as I do every night that I write a blog post, and I started reading the prior posts from my colleagues. I had every intention of writing on a different topic tonight, but something struck a chord with me when I looked through the blogs. They all had something in common. It’s something that we as regulatory and quality folks struggle with and love at the same time. It’s the topic of precedence.
In a bit of a change for today's post, I'm going to highlight some of the big news items that came through my inbox last week:
In a fantastic case of science-fiction-meets-reality, Qualcomm created the X Prize Foundation to challenge developers and innovators to create a Star Trek Tricorder. The prize? $10M!
To continue our product highlights within mobile health, we turn to Aycan's "Aycan Mobile" product which received clearance on September 12, 2012. A picture of its use on an iPad is shown on their website.
The topic of this week's post was a bit more challenging than normal. Ever since my inadvertent "reboot" of the Everyday Usability series, my brain was stuck in that frame of mind. Even today I struggled to break my mind from it.