Regulatory and Compliance
Jan 26, 2015
At MD&M West on Wednesday, February 11 from 2:45 to 4:00 p.m., James Wabby, director of quality compliance and risk management at Irvine, CA–based...
Jan 26, 2015
In October, there was love in the air in Chicago. At the annual conference of AdvaMed, the medical devices industry's largest lobby group, you couldn't go two...
Jan 23, 2015
The agency should have gone for a notice of proposed rulemaking instead of a draft guidance when it comes to its oversight of laboratory-developed tests. By...
Jan 22, 2015
  [Image Credit: iStockphoto.com user Nerthuz]  
Jan 14, 2015
A Minnesota medical device company announced Wednesday that the FDA has approved its neuromodulation therapy, noting that the device is the first the agency...
Jan 13, 2015
  The medical device tax is being collected over the past two years, but with solid Republican control in Congress, talks of a repeal has heated up. Some...
Jan 09, 2015
  Talk of medical device tax repeal is back in circulation. What was a bitter pill in 2013 and 2014 that the industry had largely swallowed is now on the...
Jan 05, 2015
The Indian government has a present for foreign medical device companies that may spur them to delve deeper into the emerging market. On Dec. 24, the Indian...
Jan 05, 2015
    The IN.PACT Admiral drug-coated balloon is inflated and inserted into the blocked artery   Medtronic announced the FDA approval of a...
Dec 17, 2014
Complaints that FDA’s busiest pathway to market for medical devices is anything but straight piled up in 2014. By Jim Dickinson Looking back, 2014 will...