January 2015

Medtech investment hits 6-year high in Minnesota

January 15, 2015 by Scott Wooldridge for MassDevice

Investment in medical device companies hit a 6-year high in Minnesota in 2014, according to data from LifeScience Alley's annual report on investing in the North Star State.

Investment in Minnesota's thriving medtech scene hit a 6-year high in 2014 and the state saw a significant jump in pharma/biotech investments, according to LifeScience Alley's annual report.

The group's "...

Cartiva Announces 510(k) Clearance for ProxiFuse Hammertoe Correction System

Posted on January 7, 2015 by Josh Sandberg for OrthoSpine News

ALPHARETTA, GA. — Cartiva, Inc., (the “Company”) a developer of innovative solutions for the treatment of cartilage damage, osteoarthritis and other musculoskeletal conditions, announced today that it has received 510(k) clearance for its...

kBLASTER update January 2015: 510(k) search for predicates and successful 510(k) clearance strategy

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)...

Medical device tax: Hatch reboots Senate repeal effort with new bill

January 13, 2015 by Brian Johnson for MassDevice

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.

Once more unto the breach, dear friends, once more: Sen. Orrin Hatch (R-Utah) and 10 other senators today filed another bill to repeal the medical device tax, a 2.3% levy on U.S. sales of medical devices...

Report: Republicans pressure Warren on medical device tax

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....

NxStage Receives FDA 510(k) Clearance For Home Nocturnal Hemodialysis

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....

MITA, AdvaMed & MDMA Support Bipartisan Efforts to Repeal the Device Tax

by Wanda Moebius at AdvaMed

January 7, 2015

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...