Regulatory/Legal
This Week in Devices [4/26/2013]: The Pain of Earnings Season
Apr 26, 2013
Some big players in the medical device industry have taken a beating according to their earnings reports. FDA has authorized a smartphone app to help doctors...
A Peek at Challenges From the Office of Combination Products
Apr 11, 2013
 FDA's Office of Combination Products (OCP) has one goal in its dealings with device makers – to be 'APT” - appropriate, predictable, and...
If You Can 3-D Print a Gun, Why Not a Medical Device?
Apr 02, 2013
Cody Wilson, a 25 year old law student at the University of Texas, has been making big headlines since a documentary about him produced by VICE magazine went...
Seriously, What is Going On at the Office of Combination Products?
Mar 27, 2013
 I’ve been hearing one question over and over in conversations over the past few weeks: “What is the Office of Combination Products (OCP)...
This Week in Devices [3/15/2013]: GOP to FDA, “Don't tax medical apps!”
Mar 15, 2013
GOP lawmakers want to know if FDA plans to tax medical software apps. A company creates a prosthetic skull implant with 3-D printing. Sensors, the next step in...
Feds Raid The Scooter Store
Mar 04, 2013
The Scooter Store, the nation's largest power wheelchair company became a target of the FBI last week. Government auditors found that The Scooter Store...
Jury Awards $3.35 Million in Vaginal Mesh Lawsuit
Feb 25, 2013
Rochelle Rottenstein is a product liability attorney and the principal of Rottenstein Law Group (New York City).  A jury in Atlantic...
Medical Device Tax Weighs on North American Companies
Feb 21, 2013
Emergo Group’s 2013 Medical Device Industry Survey points to positive views for the industry overall at 71.1%, but the cloud over the heads of North...
This Week in Devices [ 11/30/2012 ]: Prosthetics Present Challenges and Innovation
Nov 30, 2012
This Week in Devices [ 11/30/2012 ]: Prosthetics Present Challenges and Innovation This Week in Devices [ 11/20/2012 ]: Mind-controlled robotic arms are...
This Week In Devices [11/2/2012]; The Patent War Over the VAC; More Jobs Cuts at St. Jude; Taiwan's Medical Device Industry; Medical Devices in a Hurricane
Nov 02, 2012
  The story of the VAC and how it launched a patent battle. St. Jude has cut 500 jobs. Taiwan wants to expand its medical device industry. FDA issues tips...