R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

Mobile Medical Applications - Most Reliable Apps, Internationally?

A few notable posts pertaining to mobile medical applications came through my Twitter feed / Inbox recently, so I wanted to share!

Mobile Medical Applications: Make Sure uChek with FDA

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.

Mobile Medical Applications - Where do we go from here?

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?

Mobile Medical Applications - Healthcare at CES

So I wasn't kidding last week about wearable tech, which made the biggest splash at CES 2013, an annual consumer electronics expo. Coverage thanks to CNET.com.

Setting Precedence

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.

Quick Hits - December 11, 2012

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:

Mobile Medical Applications - Community Bull-Dozers

Well how about that - software developers are making it easy on me to write this series with yet another 510(k) clearance announced this week. The latest in cleared mobile health devices? The AliveCor mobile heart monitor.

Mobile Medical Applications - Beam Me Up, Scanadu

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!

Mobile Medical Applications - Aycan 510(k)

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.

Mobile Medical Applications - Difficult Usability?

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.

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