Regulatory/Legal
Sep 21, 2012
This Week in Devices [9/21/12]: Medical Device Company Conducts Illegal Human Testing; GOP vs. the Device Tax; The 10 Richest People in Medicine; A Low-Cost,...
Aug 31, 2012
This Week in Devices [ 8/31/12]: St. Jude to Cut 300 Jobs; ICDs Endangered by Europe's Financial Crisis; Turning Your Body into a Wireless Hotspot; Libel Claim...
Aug 27, 2012
We're less than five months from January 1, 2013, the date the medical device tax is set to go into effect. So far, the industry has put most of its might...
Jul 13, 2012
The LipoTron 3000. Image copyright: RevecoMED  The LipoTron 3000, also known as the Lipo-Ex, is major innovation in cosmetic...
Jul 13, 2012
 This Week in Devices [7/13/12] President Obama Signs Food and Drug Administration Safety and Innovation Act The President's has signed the bipartisan...
Jul 11, 2012
UPDATE: On 13 July 2012 IEC formally published the long awaited IEC 60601-1:05 (also known as third edition) Amendment 1 (A1).  It is on the IEC.ch...
Jul 02, 2012
Larry Spears is director, Health Sciences Industry, Deloitte and Touche, LLP and former CDRH Deputy Director for Regulatory Affairs. We asked him to draw on...
Jun 29, 2012
 This Week in Medical Devices [6/29/12] Supreme Court Upholds Affordable Care Act The Supreme Court laid down its decision on the Affordable Care Act and...
Jun 28, 2012
The Supreme Court this morning upheld most of President Obama’s Patient Protection and Affordable Care Act (ACA), a decision that means the medical...
Jun 08, 2012
This Week in Devices: [6/8/2012] House Repeals Medical Device Tax Ding-dong the tax is dead! At least in the House of Representatives as Republicans and...