FDA clearance

By Brian Dolan 08:10 am January 17, 2013
Silicon Valley-based startup Glooko announced two new executive hires this week and that its MeterSync Cable and Logbook iOS app received Class II FDA Clearance 510(k). The company appointed Rick Atlinger, who previously served as a vice president at Intuit Health, as its first CEO. Glooko co-founder Yogen Dalal filled in as interim CEO since the startup's founding. Altinger launched Intuit's...
By Brian Dolan 04:23 am September 11, 2012
Minneapolis-based Preventice announced this week that the FDA had cleared its remote monitoring device for patients with cardiac arrhythmias, the BodyGuardian Remote Monitoring System, with a 510(k) clearance. Preventice developed the system with its partner Mayo Clinic and licensed technology from Proteus Biomedical's partner Avery Dennison for the peel-and-stick sensor. BodyGuardian is a small...
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...