Submitted by kBLASTER Team on
by the kBLASTER Team
The CDRH released today the CDRH Fiscal Year 2015 Proposed Guidance Development and Focused Retrospective Review of Final Guidance. The CDRH (or the "Agency") provided three lists: (1) a list of guidance documents that the Agency fully intends to publish (the “A-list”); (2) a list of guidance documents that the Agency intends to publish as resources permit (the...
Submitted by kBLASTER Team on
ANDOVER, MA. – Royal Philips (NYSE: PHG AEX: PHIA) today announced that it received 510(k) clearance from the U.S.A. Food and Drug Administration (FDA) to market its Avalon CL Fetal Monitoring solution (Avalon CL). The solution provides consistent monitoring of the mother and child, without the burden of managing cables, allowing mothers more...
Submitted by kBLASTER Team on
by Ramin A. Khalili, USAMRMC Combat Casualty Care Research Program Knowledge Manager
The new Defense Automated Neurobehavioral Assessment is a mobile phone-based application designed to help medical providers identify cases of traumatic brain injury in almost any setting, which may help clinicians diagnose a patient in as little as five minutes.
"This is what's important right now," said Lt. Col. Chessley Atchison, as he...
Submitted by kBLASTER Team on
by Globe Newswire
ST. LOUIS, Jan. 5, 2015 (GLOBE NEWSWIRE) -- Stereotaxis, Inc. (Nasdaq:STXS) announced today that it has received 510(k) clearance by the Food and Drug Administration (FDA) for its Vdrive® with V-CAS™ Catheter Advancement System in the U.S., representing the Company's third Vdrive system product to be cleared for market entry...