| July 23, 2010 | News for medical technology professionals |
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- Entrepreneurs, investors see improvement in fundraising, deals
Although there still is lack of seed money and startup funding, entrepreneurs in the health care sector said investments are starting to improve after a decline in early 2009. Deals also are starting to increase and improve, according to angel investors and venture capitalists at the MedVentures conference in Frisco, Texas. The Dallas Morning News (free registration)
(7/22)      
| Business & Market Trends | | |
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- Zimmer, St. Jude Medical weather pricing pressure from hospitals
St. Jude Medical and Zimmer Holdings seem to be managing pricing pressures from hospitals after outpacing analysts' expectations during the second quarter. Zimmer "didn't see much change in the way of pricing pressure," said David Dvorak, the company's CEO. St. Jude Medical said its products are helping it weather greater pressure in product pricing. Reuters
(7/22)
- Cook pulls tracheostomy sets, trays from market
Indiana-based Cook has voluntarily recalled Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays because a tracheostomy tube in each device may be unable to contain air as a result of a leak in the tube's cuff. The company said it had notified consumers about the recall and advised them what steps to take to identify and replace the affected devices. MedPage Today (free registration)
(7/22)
- Ohio spinal disk maker gets $14.5M in Series D funding
AxioMed Spine has secured $14.5 million in financing that will be used to complete patient enrollment for a clinical trial of Freedom Lumbar Disk by the second quarter of next year, according to Jerry Baty, the firm's chief financial officer. The company also will use the proceeds to secure CE Mark approval for its cervical disk and commercialize it in Europe. MedCity News (Cleveland)
(7/22)
| Science & Health | | |
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| Emerging Technologies | | |
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- Robotic device can help take tissue samples in simulated organs
Duke University researchers combined a robotic arm and an ultrasound system to create a device that was able to maneuver a biopsy plunger to a lesion and take samples on simulated prostate tissue. The device, which is operated by an artificial intelligence program, might be used someday in routine procedures with minimal human supervision, said the lead researcher. The Engineer (U.K.)
(7/23)
| Government & Regulatory | | |
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- FDA withdraws pediatric data rule for regulatory applications
The FDA has decided to revoke a direct final rule that would require device firms to include data on pediatric patients in their regulatory submissions, after receiving unfavorable comments from the industry. The policy was scheduled to take effect Aug. 16. The agency will subject a companion proposed rule to the same notice and comment process in order to resolve the issue. Clinica (subscription required)
(7/21)
| AdvaMed News | | |
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FDA 510(k) Process Under the Microscope: How Will Changes Impact You?
With the FDA evaluating its mechanisms and processes for reviewing the safety and efficacy of medical devices and diagnostics, this year's program will focus on the 510(k) process and how changes will impact biomedical innovation and public health in California. The program will review current legal and regulatory perspectives on expected changes to the 501(k) system and the California medical technology industry's challenges and concerns with these proposed changes. This presentation will take place 3:30 to 9 p.m. July 29 at the Balboa Bay Club & Resort in Newport Beach, Calif. AdvaMed members will receive a $50 discount.
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See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses here.
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 Sr. Product Development Engineer | NP Medical | Clinton, MA |
| MANAGER, R&D | Abbott | Santa Clara, CA |
| Staff Programmer, Statistical | Edwards Lifesciences | Irvine, CA |
| Director Quality (THV-Manufacturing) | Edwards Lifesciences | Irvine, CA |
| Training and Education Manager | TriVascular, Inc. | Santa Rosa, CA |
| Director, Regulatory Affairs and Quality Assurance | IOS Technologies, Inc. | San Diego, CA |
| Director Commercial Compliance | NuVasive | San Diego, CA |
| Outstanding Senior Manager of Conventions - High Growth Company | Edwards Lifesciences | Irvine, CA |
| OCCUPATIONAL HEALTH NURSE | Abbott | Santa Clara, CA |
| Manager, Reimbursement Practice | Avalere Health, LLC | Washington, DC |
| Medical Technologist (Full Time Day Shift) | Calvary Hospital | Bronx, NY |
| Global Marketing Director, Mitral Portfolio | Edwards Lifesciences | Irvine, CA |
| Technical/Manufacturing Supervisor | Endologix, Inc. | Irvine, CA |
| Regulatory Affairs Manager | Endologix | Irvine, CA |
| Manufacturing Engineer | Endologix | Irvine, CA |
| Senior Director, Heart Valve Manufacturing Operations | Edwards Lifesciences | Irvine, CA |
| Sr. Product Manager | Endologix | Irvine, CA |
| Director, Health Care Compliance | Johnson & Johnson | Menlo Park, CA |
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| SmartQuote | | |
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 | If you think of yourself as the woman in the Cartier watch and the Hermes scarf, a house fire will destroy not only your possessions but your self."
--Linda Henley,
American consultant and motivational speaker
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