Tag Archives: Medical Devices

Despite Growing Momentum, Repeal of Medical Device Tax Faces Significant Hurdles

by William Kitchens On March 21, 2013, the United States Senate approved an amendment by a vote of 79 to 20 to repeal the 2.3 percent medical device excise tax. The tax, which went into effect this past January, was included as part of the Patient Protection and Affordable Care Act.
Posted in Strategy | Also tagged , , , , | Leave a comment

For Becton Dickinson, Medication Errors are a Business Opportunity

Over the next few years, med tech company Becton Dickinson will launch up to 30 generic, pre-filled syringes in an attempt to lower medication errors and raise company revenues, according to BD Rx president Mark Sebree. One man’s goof is another man’s growth, potentially.
Posted in FDA, Manufacturing, R&D, Safety, Strategy, Technology, pricing | Also tagged , , , , | Leave a comment

FDA, AdvaMed Seeking Clarity on Med Device Pre-Market Approvals

by Elizabeth Hollis The FDA and the Advanced Medical Technology Association (AdvaMed) gave cardiovascular device manufacturers plenty to think about over the holiday weekend with information presented at an Aug. 28 workshop. The two bodies came together to explain requirements for 30-day notices and annual change reports for Pre-Market Approvals (PMAs), an important gateway to [...]
Posted in FDA, Guest Blog, IP, Legal, Manufacturing, Market Access, Meetings, Regulatory, Safety, Strategy, Technology | Also tagged | 1 Comment