May 22, 2013
This week the US Food and Drug Administration sent a letter to Mountain View, California-based Biosense Technologies, maker of the uChek smartphone-enabled urinanalysis system, that instructs the company to seek 510(k) clearance of its mobile medical app or convince the FDA that such a clearance is not necessary. Sending an "it has come to our attention letter" like this is a rare action for the...
May 14, 2013
Calgary Scientific claims its ResolutionMD Mobile diagnostic imaging app was the first of its kind to regulatory clearance for use on mobile devices, though competitor MIM Software gained Food and Drug Administration 510(k) clearance for an iPhone app in January 2011, months before ResolutionMD did the same.
ResolutionMD was the first to earn Food and Drug Administration 510(k) clearance for an...
February 29, 2012
New research from Australia adds to the evidence that the iPad is a handy but still less-than-perfect tool for radiologists.
In a study presented at the recent International Society for Optical Engineering medical imaging conference in San Diego, Dr. Mark McEntee of the University of Sydney found that the iPad and similar touch-screen tablets are just as good as standard LCD monitors for viewing...
December 19, 2011
MIM Software received its second FDA 510(k) clearance this week for the latest version of its Mobile MIM radiology app. The newest FDA clearance adds support for viewing images to plan for a radiation-based treatment.
Mobile MIM is used to view high resolution diagnostic X-ray and ultrasound images downloaded from either MIM's MIMcloud cloud-based service or a workstation. With the app's latest...
November 30, 2011
GE Healthcare's Centricity Radiology Mobile Access 2.0 app received FDA (510k) clearance this week, the company announced in a press release. The mobile imaging application is a free download for Apple iOS devices and is cleared for remote viewing of computed tomography and magnetic resonance exams.
Centricity Radiology Mobile Access 2.0 accesses images and reports from the Centricity PACS (...
September 13, 2011
Investment trends, design challenges, top apps, and tablets for clinicians are often discussed in mobile health circles. This month Technology Review has put together a series on e-medicine, which included a focus on mobile health this week. Here's a quick round-up of their coverage so far:
First up is TR's trend piece on investment challenges facing healthcare startups. "The usual reason HIT...
June 1, 2011
This week MIM Software launched an app for patients that enables them to view and share diagnostic images from their physicians with other caregivers or specialists. The app, called VueMe, is available for iPad, iPhone, and iPhone touch and follows MIM Software's official launch of Mobile MIM. The FDA gave Mobile MIM a 510(k) clearance earlier this year and dubbed it the first diagnostic...
April 4, 2011
The FDA cleared Abbott's i-STAT 1 Wireless point-of-care blood analyzer last week, marking the fourth wireless-enabled medical device to receive FDA clearance so far this year. Ascom, Monica Healthcare and Mobisante have each received a 510(k) clearance this year for a connected medical device. The FDA has cleared more than a dozen software apps for mobile devices over the years including one...
March 30, 2011
A special report on “Innovations in Health Care” that appeared in the Wall Street Journal on Monday included a feature on mobile devices.
Most of what the Journal reported shouldn’t be a surprise to anyone who reads MobiHealthNews: Dr. Eric Topol, chief academic officer at Scripps Health in San Diego, thinks the pocket ultrasound is ending the 200-year reign of the stethoscope. Telemedicine...