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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...
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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...
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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...
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By Val Kennedy for MassDevice
Brainlab said it won FDA 510(k) clearance for a mobile version of its TraumaCad surgical planning software for hip replacement procedures.
The product, TraumaCad Mobile, will be marketed by Brainlab's Voyant Health unit. The application is compatible with Mac and PC web browsers plus...
Submitted by kBLASTER Team on
The kBLASTER database has been updated today with FDA 510(k) clearances from February 2015 and FDA 510(k) splash pages for 510(k)s clearances in March 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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Los Altos, Calif., March 16, 2015 – Gauss Surgical today announced that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Triton Canister App, the second core product in its Triton System™ portfolio, the world’s first and only mobile platform for real-time monitoring of surgical blood loss. Now, in addition to estimating blood loss on surgical sponges, the system can accurately estimate blood...
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by BusinessWire
MUNICH--(BUSINESS WIRE)--TomTec Imaging Systems GmbH announces the FDA 510(k) clearance for its innovative TomTec-ArenaTM software solution.
...
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On February 24, FDA hosted a webinar with an accompanying slide deck to discuss final guidance documents on medical device data systems (MDDS) and mobile medical apps (...
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by Fort Mill Times
VALENCIA, CALIF. — Bioness, Inc. announced that the U.S. Food and Drug Administration (FDA) has 510(k) cleared the StimRouter®, an implantable neuromodulation device designed to treat chronic, intractable pain of peripheral nerve origin. The StimRouter is the only implanted device to be cleared by the FDA with a specific indication for peripheral nerve stimulation.
With an estimated 50 million people suffering...