Full article reprinted from"The Gray Sheet" - September 28, 2009
Social media sites like Facebook and Twitter can serve as an invaluable marketing resource for medical device and drug companies, but as FDA works to develop guidance on the issue, companies should be careful to control the content of their Web postings, marketing experts caution. Read more...
Article preview reprinted from"The Gray Sheet" - September 28, 2009
An internal evaluation of FDA's handling of the controversial 510(k) clearance of a knee implant unearthed serious shortcomings in the integrity of the agency's review process, FDA said Sept. 24. Read more...
Calypso Medical Technologies (implantable devices for tumor localization and monitoring) raised $50mm through a venture round co-led by founding backer Frazier Healthcare Venture and new investor Skyline Ventures.
Article preview reprinted from Medtech Insight - July/August 2009
C. Daniel Smith, MD, recently sat down with Medtech Insight to discuss trends in minimally invasive surgery and the single-incision laparoscopic approach. Smith is the current president of the Society of American Gastrointestinal Endoscopic Surgeons (SAGES), and professor of surgery and chair of the surgery department at the Mayo Clinic, Jacksonville, FL. Read more...
Article preview reprinted from IN VIVO archives - May, 2009
Minimally invasive surgery, performed through a number of ports to create access and enable visualization, manipulation, and dissection, promised to revolutionize surgical techniques two decades ago, but ultimately fell short of changing the way surgeons perform the majority of surgical cases. Now, the next generation in minimally invasive surgery sees single-port surgeries and natural orifice transluminal endoscopic surgeries (NOTES) gaining momentum. TransEnterix aims to operate in both cases, with a novel approach that not only allows surgeons greater dexterity in performing complex procedures, but also enables them to do surgical cases through a single access port, using the body's umbilicus. Read more...
Full article reprinted from"The Gray Sheet" - September 21, 2009
Japan is rolling out a new three-track medical device review system based on the novelty of the product, Japanese device reviewers said last week. Read more...
Two key proposed rules from FDA's Office of Combination Products have finally received Office of Management and Budget approval and should be out for comment in the coming weeks, according to OCP Director Thinh Nguyen. Read more...
Article preview reprinted from"The Gray Sheet" - September 21, 2009
The device industry lobbying machine has accelerated in opposition to Sen. Max Baucus' plan for a $40 billion fee on manufacturers in the lead up to Finance Committee health reform mark-up sessions this week. Read more...
