| March 7, 2013 | News for medical technology professionals |
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- Medtronic obtains approval for cardiac leads in Europe
Medtronic has received the green light in Europe for its Attain Performa line of quadripolar leads, which are used with the company's Viva/Brava cardiac resynchronization therapy defibrillators. The devices are equipped with features that aid doctors in providing personalized care to heart failure patients, a company official said. MassDevice.com (Boston)
(3/6)      
| Business & Market Trends |  |  |
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- MxBiodevices seeks $8 million for diabetic foot ulcer study
MxBiodevices is hoping to raise $8 million to support a pivotal trial of its E-Matrix bioscaffold, which is intended to help treat wounds in patients with diabetic foot ulcers. The Greenville, N.C.-based company will use the trial to back its FDA premarket approval application for the device, which already has 510(k) clearance for spine and orthopedic uses. MedCityNews.com
(3/6)
- CEO of Stereotaxis leaves post
Michael Kaminski is resigning as president and CEO of Stereotaxis, effective on April 12. The company's board has tapped Chairman William Mills III to serve as CEO on an interim basis and has enlisted Director Euan Thomson to help with the transition to new leadership. RTT News
(3/5)
| International Developments | | |
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- Mobile oncology application from ONCOassist gets CE mark
ONCOassist has received the CE mark in Europe for a smartphone application designed to give oncologists mobile access to point-of-care clinical decision support tools. The ONCOassist app was designed for the iPad and iPhone, but the Irish company plans to have the technology available for Android devices in six to 12 months. Silicon Republic (Ireland)
(3/6)
| Industry Insight | | |
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| Science & Health | | |
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- Method could prevent GVHD in bone marrow transplants
Blocking the Notch signaling pathway in donor cells may reduce the risk of graft-versus-host disease after bone marrow transplants, a University of Michigan team reports in the Journal of Clinical Investigation. Targeting a ligand-receptor pair in the Notch signaling pathway prevented the disease in mice and did not cause adverse effects or affect the ability of the transplanted cells to fight cancer, according to the study. The findings open new routes for possible treatments of T cell-related conditions in transplants, an investigator said. Genetic Engineering & Biotechnology News
(3/1)
| Emerging Technologies | | |
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| Government & Regulatory | | |
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- 6th Annual FDA/MTLI Medical Devices and IVD Statistical Issues Workshop
Tuesday, April 23 – Wednesday, April 24
Sheraton Crystal City, Arlington, Va.
This annual conference, co-sponsored by the FDA and AdvaMed, brings together leading authorities from the FDA, industry and academia to address statistical topics such as CDISC, data standard, FDA guidances, sample size estimation and re-estimation, and more. On Day 2, the conference will be split into focus areas: therapeutic devices and IVD products addressing guidance documents; a report from the equivocal results sub-group; combination products; and technology-related issues. Visit MTLI online for more information.
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| Position Title | Company Name | Location |
| Sales Area Manager/Sales Rep of Neurovascular Intervention Products | Asahi Intecc USA, Inc. | Any location in US, CA |
| Compliance Consultant 2 | DJO Global | Vista, CA |
| Accreditation Manager | American Association of Tissue Banks | McLean, VA |
| REGULATORY AFFAIRS SPECIALIST | Masimo Corporation | Irvine, CA |
| Director, Health Care Compliance | RTI Biologics | Alachua, FL |
| Director of Global Infrastructure - 002196 | Edwards Lifesciences | Irvine, CA |
| Manager, HCL Regulatory & Quality Compliance | Owens & Minor | Louisville, KY |
| DIR OPERATIONS, Milpitas Site - 130000007R | Abbott | San Jose, CA |
| Engineer, Process Development | ArthroCare Corporation | Irvine, CA |
| Biostatistician - Post Market Surveillance | Johnson & Johnson | Raynham, MA |
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 | Scientific progress makes moral progress a necessity; for if man's power is increased, the checks that restrain him from abusing it must be strengthened."
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