Regulatory/Legal
Can HIPAA Move Into the 21st Century?
May 17, 2013
When the Health Insurance Portability and Accountability Act, better known as HIPAA, was passed in 1996, AOL was just beginning to crawl and the iPhone was...
This Week in Devices [5/17/2013]: Dying Better, Scam Artists, and the End of Moore's Law
May 17, 2013
A doctor fights for a lower-tech, higher-empathy approach to end-of-life care. A career con man exposes how Google AdWords helped him run an illegal online...
Recall Round-up: GemStar Infusion System, and GE Healthcare's Giraffe Products Among those Recalled in April and Early May.
May 10, 2013
Hospira Inc., GemStar Infusion System: Recall Posted 4/29/13, Updated 5/1/13 Damage from battery leakage may cause the device to shut off without warning. The...
This Week in Devices [5/3/2013]: China Wants To Boost Its Innovative Device Industry
May 03, 2013
China's FDA wants to boost the country's innovative device industry. A response to new European legislation on medical devices. University students' medical...
Op-Ed: What Do “The Hunger Games” and 510(k) Have in Common? More Than You’d Think.
Apr 29, 2013
Like the tributes thrust into the Hunger Games arena, medical device manufacturers want a fair shot at surviving the ever-changing FDA 510(k) pathway. By...
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...