Submitted by kBLASTER Team on
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Nipro Diagnostics, Inc., announced today that the U.S. Food and Drug Administration (FDA) has 510(k) cleared its TRUE METRIX® AIR Self-Monitoring blood glucose system - a device for people with diabetes to test blood glucose and deliver data wirelessly to a smartphone.
As the diabetes store-brand leader and largest U.S. manufacturer of...
Submitted by kBLASTER Team on
The kBLASTER database has been updated today with FDA 510(k) clearances from March 2015 and FDA 510(k) splash pages for 510(k)s clearances in April 2015. If you have Saved Searches in your kBLASTER account that meet the parameters of today's imports into the kBLASTER database, you will see blue notification flags in your active kBLASTER account on those Saved Searches, as well as Alert email(s).
With more than 60,000 510(k)...
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Posted by Ambient Clinical Analytics
Rochester, MN (April 6, 2015) Ambient Clinical Analytics announced today it received 510(k) U.S. Food and Drug Administration (FDA) clearance for AWARE. AWARE is a clinical decision support tool, combined with a scientifically supported...
Submitted by kBLASTER Team on
Vital Art and Science, developers of myVisionTrack, a vision test service for patients with age-related macular degeneration or diabetic eye disease, has received a second FDA 510(k) clearance for their platform, which includes an app and a provider dashboard. They will also soon launch a major clinical trial in partnership with the Scripps Translational Science Institute and...