Medical Devices Today

Shuren's Center: FDA Device Chief Discusses Long Road To 510(k) Reform

Article preview from "The Gray Sheet" - August 30, 2010

FDA has put its proposals on the table for reforming the 510(k) pre-market clearance program, but the crucial activity will take place over the coming weeks as FDA fields comments and decides which initiatives will get the green light.

FDA Targets Personalized Knee Surgery Systems With Warning Letters

Article preview from "The Gray Sheet" - August 25, 2010

CDRH has sent warning letters to two different orthopedic firms in the past month charging that the companies' personalized knee surgery instrumentation systems are being marketed without proper clearance or approval.

Philips Contributes To $250 Million Venture Fund For Health-Tech Firms

Medtronic CFO Says Surprised By Boston Sci Recovery Speed

J&J’s DePuy Told By FDA To Halt Illegal Marketing Of Two Products

Roche Unit To Acquire Diagnostic Maker BioImagene For $100 Million

J&J Vision Care Recalls 100,000 Boxes Of Daily Contact Lenses

Boston Sci’s Merged Employees Get To Cheer After Troubled Months

Edwards, Gambro Could Face FDA Rule Changes For Fluid Tubes

Medtronic Sees Start-Up Competition As It Seeks Wireless Pacemaker

Hologic, Single-Product Conceptus Agree To Limit Vying Patent Suits

Boston Scientific Remains Subject Of Iraq Suit Alleging Kickbacks

Siemens In Deal With Calypso To Market Radiation Tech In Europe

Bard Patent Suit Draws Response From Atrium, Endologix Targets

Becton, Dickinson To Add Support-Services Operation In San Antonio

J&J To Redo Quality-Control Operations In Wake Of Several Recalls

Biomet Gets FDA Warning Letter For Marketing Device Before Approval

The Artificial Disc Bust: Lessons Learned

Article preview from Medtech Insight- August, 2010

The artificial disc market, at least in the US, has yet to take off. In 2009, sales of artificial discs reached close to $150 million a far cry from the $1+ billion projected in 2005. So what happened and what does the future hold?

Cadence, VCs Relieve J&J;'s Pain, Map Out A Clever Exit In The Process

Article preview from Start Up - July, 2010

When J&J offered to sell its Ionsys pain-relief patch at a fire-sale price last year, Cadence Pharmaceuticals' management team saw a diamond in the rough. But the specialty pharma didn't have the cash or the focus to take on a new project. Enter Frazier Healthcare Ventures, which organized an investor syndicate that teamed with Cadence management on a deal with enough moving parts to make Rube Goldberg proud. The arrangement birthed Incline Therapeutics Inc., an independent, privately held start-up backed by $43.5 million in venture money.

Venture HHS: Planned Gov't Fund For Emergency Products Elicits VC Caution

Article preview from "The Gray Sheet" - August 23, 2010

The Obama administration plans to ask Congress to authorize an independent strategic investment fund to provide financial support for small companies developing medical products that can be used to respond to bioterror attacks, pandemic flu outbreaks or other public health emergencies.

Medtronic To Buy Osteotech In $123 Million Friendly Takeover

 

Boston Scientific Said Negotiating $1.5 Billion Device Unit Sale To Zimmer

S&N, KCI Get Split Decision By German Court In Patent Dispute

Alcon Stands To Get Higher Buyout Offer By Novartis, CEO Hints

Philips CT Scanner Shows Gold Particles Attracted To Fatal Plaque

Several St. Jude Catheter-Implanters Recalled For Breakage Risk

Medtronic, Zimmer Bone Products Stand To Take Medicare Hit

Medtronic, Zimmer, J&J Doctor Payments Abroad Invite Federal Probe

Biomet To Add 278 Jobs In Two-Year Expansion, Improvement Plan

Thermo Fisher To Close R.I. Facility, Move 65 Jobs To Texas, Va.

Medtronic Wins Spat With St. Jude Over Timing Of Executive Job Switch

Stryker CEO Named To U.S. Panel Advising On Manufacturing Issues

Boston Science Reports Compliance With FDA Four-Year Plant Complaints

“C.R. Bard Unit’s Patent Allegations Untrue, Endologix Says”

Roche Diagnostics Faces Rare U.S. Suit Over Expired Patent

Wound Care: Finding a Niche

Article preview from Medtech Insight - August, 2010

The relatively open nature of the wound care market has created a golden opportunity for manufacturers to step up and introduce a variety of new products, although rarely is new a signal of true innovation in this space. And that, in turn, has created a broad, diverse, and fragmented industry, as demonstrated by the packed exhibit hall at the April 2010 meeting of the Symposium on Advanced Wound Care and the Wound Healing Society.

Creating a Winning Medtech Business Model for a Post-Reform World

Article preview from IN VIVO - July, 2010

Together, the global financial crisis and health care reform could combine to dramatically alter the device industry's traditional business model. The result could be a variety of different models arising from shifting relationships with physicians and hospitals, with the winners being companies that adapt most effectively to this changing environment.

EndoControl SAS

Article preview from Start Up - July, 2010

EndoControl's founders bet there are large market applications where surgeons will want to reach for a single-function, low-cost robot to lend a helping hand. EndoControl has developed the ViKY system, a motorized endoscope holder compatible with any endoscope, that responds to a surgeon's voice or foot command.