| November 6, 2009 | News for medical technology professionals |
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- California forum to attract more than 650 device industry execs
OCTANe's California Medical Device & Investor Forum that will start on Monday in Irvine, Calif., is expected to attract more than 650 executives to tackle trends and opportunities for investment in the medical-device industry. The event will start with a discussion on the acquisition of CoreValve by Medtronic for more than $700 million and other recent industry deals in Orange County, Calif. OC Metro (Newport Beach, Calif.)
(11/5)
      
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- W.L. Gore seeks approval of bonds to fund expansion in Phoenix
W.L. Gore & Associates will ask the city of Phoenix to approve bonds worth up to $30 million to help fund a $100 million project as part of its expansion in the city. The expansion plan includes the establishment of two manufacturing facilities and is expected to generate 500 permanent jobs. The progress of the expansion will be influenced by the firm's growth and approval of devices for cardiovascular diseases and other treatment areas, said the company's corporate counsel. The Arizona Republic (Phoenix)
(11/5)
- Facet Solutions raises $3.6M in funding
Facet Solutions, which makes and markets surgical devices used to treat spinal disorders, has secured $3.6 million in financing, according to a Securities and Exchange Commission filing. The company will use the proceeds to conduct an investigational device exemption study that will be used in seeking premarket approval for its device. Mass High Tech
(11/5)
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| International Developments |  | |
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| Emerging Technologies | | |
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- Implantable device senses neural activity in moth
A team of electrical engineers at the University of Washington has developed a low-power implantable sensor, called NeuralWISP, that can detect neural activity in a moth. "Our goal is to shrink everything onto a single chip and reduce the power consumption of these components so that the chip can be wirelessly powered," the lead researcher said. MIT Technology Review
(11/5)
| Government & Regulatory | | |
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- FDA issues reminder to clarify cybersecurity issues
The FDA issued a notice saying it does not regulate changes to medical device software developed for cybersecurity purposes. The agency also advised device firms to be responsible when it comes to addressing computer viruses and other cybersecurity threats, as well as collaborate with hospitals and clinics to solve such issues. Clinica (subscription required)
(11/5)
- Trial sites to be fined if they don't disclose privacy breaches
A provision in the American Recovery and Reinvestment Act of 2009 requires clinical-trial facilities to disclose privacy breaches to patients. Those breaking the rule could pay a fine of as much as $50,000 per violation, with penalties slated to be enforced starting Feb. 23. Affected individuals must be notified of the breach within 60 days of discovery, according to the policy. HealthImaging.com
(11/6)
- House Democrats seek 218 votes to pass health care bill
As a likely weekend vote on a sweeping overhaul of the U.S. health care system draws closer, House Democratic leaders intensified their efforts to line up the 218 votes they need to pass the measure. Party leaders said they didn't have enough confirmed votes to guarantee passage but were confident of having them by the time the bill comes to the floor of the House of Representatives, probably Saturday. The New York Times
(11/5)
, The Washington Post
(11/6)
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MDRs, eMDRs and Global Adverse Event Reporting
This two-day program, offered each fall, covers current practical and policy issues in U.S. and international adverse event reporting. The most recent program helped launch FDA's new electronic reporting procedures, but the content changes annually according to regulatory developments and industry needs. More information. Medical Technology Learning Institute -- Education Beyond a Degree
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AdvaMed's MTLI is offering a $250 discount on all remaining 2009 courses. Courses include MDRs; Clinical Trials; and Combination Products. Full agendas and logistical information can be obtained on our Web site. In order to receive your discount, please contact Katia Kunze at (202) 434-7237. Some restrictions apply.
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