FDA clearance

By Brian Dolan 12:49 pm August 22, 2012
San Diego-based Sotera Wireless announced this week that the FDA had given its 510(k) clearance for the full version of its WiFi-enabled ViSi Mobile patient monitoring system, a part of which received an FDA clearance this past March. The full system enables care providers to review near real-time transmissions of patients vital signs no matter if their patients are in their beds or walking...
By Neil Versel 11:56 am June 13, 2012
We are getting closer to the day when a smartphone app can detect atrial fibrillation in patients at high risk of a stroke or heart failure. Researchers at Worcester Polytechnic Institute in Worcester, Mass., have submitted an application to the Food and Drug Administration for 510(k) approval of an Android app that can pick up subtle changes in skin color by scanning blood vessels, thanks to an...
By Brian Dolan 01:14 am April 3, 2012
About a year ago we noticed a YouTube video demo of a DIY project: An infrared thermometer iPhone peripheral. While it appears to be a separate effort altogether, Germany-based Medisana is making some noise this week about the planned launch of ThermoDock. The device is available for pre-order in the UK for about US $96. Here's the pitch over at online shopping site Firebox: "Forget old-fashioned...