| November 4, 2009 | News for medical technology professionals |
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- Senate panel's sunshine provisions to shed light on doctor-industry ties
The Senate Finance Committee has included in its health reform bill sunshine provisions that would promote transparency among drug and medical device makers that work with doctors for consultations and speeches. AdvaMed backs the sunshine initiative, saying doctor-industry relationships "are the ones the public has the keenest interest in understanding." The New York Times
(11/3)
      
 | eMDR Mandate Announced — What's Next? The long awaited electronic medical device reporting (eMDR) train is finally leaving the station; and it's due to arrive in mandatory form around February 2011. What should you do now? To help you better understand this important transition, request your white paper today. |
- Nerites names device firm CEO as new board member
Nerites, a maker of synthetic bioadhesives for post-operative purposes and tissue repair, has appointed Lisa Earnhardt, president and CEO of device firm Sinexus, to its board of directors. "As the company solidifies plans for additional corporate partnerships and new financing, Lisa's strategic input will be invaluable," said George Arida, chairman of Nerites. American City Business Journals/Milwaukee
(11/3)
 | Free Webinar: Impact of Revisions to EU Medical Device Directive As of March 21, 2010, compliance to the Revised European Medical Devices Directive will become mandatory. Join us on November 19, 2009 for this important two part Webinar: Part 1: Overview for Medical Device Manufacturers Part 2: What the Changes Mean for BSI Medical Device CE Marking Customers. |
| International Developments |  |  |
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 | Download this free white paper on Governance, Risk and Compliance: Complying with regulations and managing penalties for failing to operate within the rules requires both money and time. Organizations that can master the procedures and tasks that bear upon compliance operate more efficiently, compete more effectively and build their brands and good names in the marketplace. |
| Science & Health | | |
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- MR spectroscopy prior to radiation therapy beneficial to cancer patients
 A study showed that using magnetic resonance spectroscopy to determine the more aggressive areas in a glioblastoma multiforme tumor followed by high-dose radiation from gamma knife radiosurgery combined with standard radiotherapy increased patients' survival rates by 3.7 months compared with using conventional radiotherapy alone. "The four-month increase is quite significant as the median survival of patients treated with conventional radiotherapy alone is only one year," the lead author said. HealthImaging.com
(11/3)
| Emerging Technologies | | |
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- Blue Belt hopes to sell bone-cutting tool soon
Blue Belt Technologies hopes to commercialize within a year its Precision Freehand Sculptor, a computer-aided tool used for cutting bones during orthopedic surgeries, said CEO Craig S. Markovitz. Laboratory tests show that the device could help improve surgical outcomes and safety, said Dr. William Welch, chief of neurological surgery at The Pennsylvania Hospital, who tested the device in a lab setting. Pittsburgh Tribune-Review
(11/4)
- ATS reports implantation of heart valve during robot-aided surgery
ATS Medical announced that its ATS 3f Aortic Bioprosthesis cardiac valve has been implanted during the first robot-aided valve replacement surgery using Intuitive Surgical's system. The flexible heart valve can be implanted through minimally invasive procedures without the need for supporting stents. Reuters
(11/2)
- FDA clears PerkinElmer's genetic screening processor
The FDA has granted 510(k) clearance to PerkinElmer for its genetic screening processor designed to help public health laboratories screen newborns for genetic, hematologic or metabolic conditions. The GSP tool can enable laboratories to run multiple tests on very small blood samples. The Boston Globe
(11/3)
 | Need to increase market share and build your life science and biotech customer base? See how Pilgrim Software used online media to drive stellar results this year with SmartBrief. Case study now available (free for SmarBrief subscribers). |
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| Government & Regulatory | | |
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- FDA unveils guidance for H1N1 virus diagnostic test makers
The FDA has released a set of guidelines designed to help makers of H1N1 flu virus diagnostic tests apply for emergency use authorization. "During this declared public health emergency, manufacturers of 2009 H1N1 influenza virus tests that are unable to submit a complete premarket notification may use the guidance to submit a request for an [Emergency Use Authorization]," the agency said. Clinica (subscription required)
(11/3)
- Group: Medicare cuts would reduce community-based imaging
The increase from 50% to 90% of the assumed Medicare equipment use rate as part of the 2010 Medicare Physician Fee Schedule would reduce community-based imaging and limit imaging services to large hospitals, which could lead to delayed diagnosis of serious conditions, a radiology group said. "Many hospitals are not equipped to handle the substantial influx of patients that could result from the inevitable closure of rural and suburban imaging facilities caused by these cuts," one of the group's officials said. HealthImaging.com
(11/3)
- State-level efforts against imaging self-referral under way
Government agencies and insurance companies at the state level have implemented steps to rein in imaging self-referral. Some of the measures include California Assembly Bill 2794 and Connecticut Public Act 09-2006, which would prevent doctors from billing for the technical component of CT, MRI or PET if they have not personally performed the service. The efforts could be replicated in other states, self-referral opponent Dr. David Levin said. Diagnostic Imaging
(11/2)
| AdvaMed News | | |
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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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Sign up now for $250 discount
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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