FDA clearance 510(k)

NHS drones
By Dave Muoio July 30, 2018
Look to the skies. A recent report by Nesta, a global innovation foundation, conducted in collaboration with five UK cities suggests that no small number of regulatory and infrastructural obstacles stand in the way of medical drone deliveries in the country. While the technology could increase the testing speed and decrease costs for the UK’s National Health Service, the country would need to...
By Jonah Comstock February 19, 2014
Carestream has received FDA clearance for VUE Motion, a mobile radiology viewing and reading software that can be accessed on iPhone 4s, iPad 2, Galaxy Note and Galaxy S III mobile devices. Notably, the clearance allows radiologists to read, not just view the images, which means they can make clinical reports based on them. "If a radiologist has access to other workstations, we recommend that...
By Neil Versel September 19, 2013
Departing national health IT coordinator Dr. Farzad Mostashari would prefer that the Food and Drug Administration unilaterally issue a long-anticipated final guidance on mobile medical apps rather than waiting for inter-agency consensus with the Federal Communications Commission and Mostashari's own Office of the National Coordinator for Health Information Technology. "I testified before Congress...
By Jonah Comstock April 8, 2013
The FDA has granted Class II prescription-only 510(K) clearance for an iPhone-enabled vision test. The software, called myVisionTrack, was developed by Vital Art and Science. The FDA clearance applies to the software when run on an iPhone 4S. Vital Art and Science has developed the test for patients with serious degenerative eye conditions such as diabetic retinopathy (DR) and age-related macular...
By Chris Gullo 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...
By Chris Gullo 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 (...
By Chris Gullo September 30, 2011
Amcom Software announced this week FDA 510(k) clearance for its Amcom (Commtech) Messenger middleware as a class II medical device intended for hospital use. The Amcom Messenger middleware sends critical secondary notifications from patient monitoring and other alert systems to staff carrying wireless communication devices, including smartphones, pagers, and Wi-Fi phones. "Systems like this --...
By Brian Dolan March 2, 2011
In late January and with an eye on HIMSS 2011, Cisco's partner Extension Inc. issued a press release announcing that it had submitted its HealthAlert for Nurses offering to the FDA for clearance. Is said that the FDA could find no communications tool on the market that was "substantially equivalent" to HealthAlert for Nurses. “This submission for FDA clearance culminates two years of research and...