FDA panel to review CoAxia's NeuroFlo catheter
October 11, 2012 by MassDevice staff
The FDA's Neurological Devices Panel will next month review CoAxia's NeuroFlo catheter for treatment of cerebral ischemia.
Privately held CoAxia Inc. landed a date with the FDA's Neurological Devices Panel to submit its NeuroFlo catheter for de novo approval.
The Minneapolis-based company's NeuroFlo device, which already has CE Marking for the European Union, aims to divert blood flow in the brain for patients suffering cerebral ischemia as a result of stroke, vasospasm, or other conditions.
The device boasts 35-50% improvement in cerebral perfusion and can be placed in 10-15 minutes via the abdominal aorta, according to the company's website.
News Well, Catheters, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance
- Show full page
- Login to post comments
-
Permalink
RECENT BLOG POSTS
- Is Valeant About To Make A Bold Bid For Bausch & Lomb?
- When regulators are ignored
- FDA Issues Draft Guidance to Help Companies Distinguish Between a Voluntary Medical Device Recall and a Product Enhancement
- Patient and family engagement in ICUs
- A day in the life: A pediatric neurosurgeon's vision
- Medical Device Tax: Are Conservatives' goals hampering repeal efforts?
- Personal health record use by adolescents
- Can Johnson & Johnson fire on all cylinders again?
- U.S. FDA to require proof of IEC 60601-1 3rd Edition in summer 2013
- A cure for coffee breath?
Navigation
NEWS
Uroplasty touts positive 3-year outcomes for neurostimulation in treatment of overactive bladder
Covidien’s 3-year study results showing positive outcomes for its Urgent PC Neuromodulation system in...
FDA clears 21-inch medical monitors from NEC Display Solutions
NEC Display Solutions wins 510(k) clearance for its 21-inch medical monitor systems.
Johnson and Johnson executive splits for the corner office at Itamar Medical | Personnel Moves
J&J's former head of global cardiology makes the jump to CEO at Itamar Medical
Sunshine Heart seeks $25.5M in equity funding round | Wall Street Beat
Sunshine Heart raises $1.5 million of a hoped-for $25.5 million equity funding round.
J&J sues Shasta Technologies for logo infringement
J&J subsidiary Lifescan asks the courts to ban Shasta from using its logo, saying problems with...
