Submitted by kBLASTER Team on
by Ronny Bacharach on January 7, 2015. Posted in News & Events
First PACS to Enable Zero Footprint Full-Featured Diagnostic Viewing
GARNER, NC– (Jan 7, 2015) – Viztek, a digital radiology and health IT innovator, today announced the
Submitted by kBLASTER Team on
The kBLASTER database has been updated today with FDA 510(k) clearances from December 2014 and FDA 510(k) splash pages for 510(k)s clearances in January 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 59,000 510(k)...
Submitted by kBLASTER Team on
Sen. Orrin Hatch (R-Utah) and a bipartisan group of 10 U.S. senators file a bill to repeal the 2.3% medical device excise tax.
Submitted by kBLASTER Team on
Submitted by kBLASTER Team on
January 12, 2015 by Brad Perriello at MassDevice
Republican strategists ratchet up the pressure on Sen. Elizabeth Warren (D-Mass.) on her support for repealing the medical device tax, as the GOP looks to dismantle Obamacare.
Republicans are reportedly trying to raise the pressure on Sen. Elizabeth Warren (D-Mass.) to support repealing the medical device tax, a position she's taken since before winning her seat in the U.S. Senate.
Back in April 2012, as she battled then-Sen....
Submitted by eric on
by PRNewswire
Lawrence, MA /PRNewswire/ - NxStage Medical, Inc.(NASDAQ: NXTM), a leading manufacturer of innovative dialysis products, announced today that the U.S. Food and Drug Administration (FDA) has 510(k) cleared its System One™ to perform hemodialysis overnight while the patient is at home sleeping, known as home nocturnal hemodialysis....
Submitted by kBLASTER Team on
by BusinessWire
IRVINE, Calif.--(BUSINESS WIRE)--HEPATIQ LLC announced that they received 510(k) clearance from the United States Food & Drug...
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by Wanda Moebius at AdvaMed
The Medical Imaging & Technology Alliance (MITA), Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA) today applauded the introduction of bipartisan legislation to repeal the 2.3 percent medical device excise tax. The legislation, H.R. 160 “The Protect Medical Innovation Act,” was sponsored by Reps. Erik Paulsen (R-MN) and Ron...
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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...
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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...