| July 12, 2012 | News for medical technology professionals |
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- St. Jude Medical's echocardiography catheter gets FDA OK
The FDA has given St. Jude Medical 510(k) clearance to market the ViewFlex Xtra intracardiac echocardiography catheter, which aids doctors in viewing the heart's anatomy during interventional or electrophysiology procedures. The device is cleared for use with the ViewMate Z ultrasound console, which St. Jude co-developed with Zonare Medical Systems. MassDevice.com (Boston)
(7/10)      
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| Business & Market Trends |  |  |
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- Biopsy device maker boosts Q2 revenue with European deal
SpectraScience, a maker of light-based biopsy devices in San Diego, said it anticipates raising about $310,000 in revenue during the second quarter. The revenue forecast comes after the company started distributing its optical biopsy device to Pentax Europe as part of a 23-country supply deal it struck last month, CEO Michael Oliver said. San Diego Business Journal
(7/12)
| International Developments | | |
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| Industry Insight | | |
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| Science & Health | | |
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- Rcadia's imaging analysis tool shows positive trial results
Rcadia Medical Imaging said its COR Analyzer System proved almost as effective as a catheter-based method in measuring the effect of coronary stenosis or narrowed arteries on a patient's blood flow. The company said the device accurately detected 33 out of 38 hemodynamically insignificant lesions and all 11 hemodynamically significant lesions in a 44-patient study. Mass High Tech (Boston)
(7/10)
- Echo, nuclear stress test can predict risk after revascularization
 Results on stress echo and stress radionuclide myocardial perfusion imaging can indicate the likelihood of worse outcomes in asymptomatic patients after revascularization, according to a study presented at an echocardiography meeting. The meta-analysis reviewed 37 studies involving 11,790 patients. Researchers said the usefulness of the two tests in this patient group is still undetermined. TheHeart.org (Montreal) (free registration)
(7/6)
| Emerging Technologies | | |
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- Panasonic unveils medical-grade surgical monitor
Panasonic has introduced the EJ-MDA32U-K, a medical-grade monitor tailored for use in the surgical suite. The device lets clinicians view 2-D and 3-D medical images from multiple sources simultaneously, allowing for improved surgical experience and patient outcomes, according to the company. Healthcare IT News
(7/11)
| Government & Regulatory | | |
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- FDA clears MRSA test from BD Diagnostics
The FDA has allowed BD Diagnostics, a unit of Becton, Dickinson and Co., to sell the BD MAX MRSA molecular test. The assay, which runs on the BD MAX system, offers a cost-effective and convenient way to pinpoint patients infected with MRSA, a company official said. BeckersASC.com
(7/10)
- 510(k) Submissions Workshop
Monday, Oct. 15 – Tuesday, Oct. 16
Sheraton Crystal City, Arlington, Va.
This interactive workshop, taught by industry experts and key personnel from the CDRH 510(k) staff, leads participants step by step through the regulatory guidelines, practical steps and strategic considerations for determining a product’s regulatory route to market, identifying a predicate device, planning and assembling a 510(k) submission, interacting with the FDA during the review process, and dealing with post-clearance issues. Visit MTLI online for more information.
- Medical Device Reimbursement Workshop
Tuesday, Oct. 16 – Wednesday, Oct. 17
Sheraton Crystal City, Arlington, Va.
AdvaMed MTLI’s workshop for medical technology reimbursement professionals will provide the road map to successfully navigate the many potential pitfalls. After an overview of reimbursement issues, the workshop will drill down to coding systems, technology assessments and differences in inpatient and outpatient payment systems. Hear from experts on how to negotiate CMS coverage. Learn how to plan for the new health care reform landscape, deal with comparative effectiveness and manage international reimbursement. Visit MTLI online for more information.
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| Position Title | Company Name | Location |
| Senior Indirect Sourcing/Supply Chain Analyst | Edward Life Sciences | Irvine, CA |
| Senior Counsel - Regulatory Law | Johnson & Johnson | New Brunswick, NJ |
| Clinical Field Associate | SentreHEART, Inc. | East, Midwest, West Territories, United States |
| Senior Counsel - Regulatory Law | Johnson & Johnson | New Brunswick, NJ |
| Director, Public Affairs | AdvaMed | Washington, DC |
| Clinical Project Manager | Zimmer, Inc. | Warsaw, IN |
| Manager, Learning Content Infrastructure 001493 | Edwards Lifesciences | Irvine, CA |
| Distributed Sales Operations & Relationship Manager 001373 | Edwards Lifesciences | Irvine, CA |
| Senior Global Product Manager, Tissue Programs, New Product Development – Heart Valve Therapy-001476 | Edwards Lifesciences | Irvine, CA |
| Documentation Coordinator - Heart Valve Therapy - 001453 | Edwards Lifesciences | Irvine, CA |
| Staff Engineer, Embolic Protection - Transcatheter Heart Valve | Edward Life Sciences | Irvine, CA |
| Staff Engineer, Embolic Protection - Transcatheter Heart Valve 001497 | Edwards Lifesciences | Irvine, CA |
| Director, Quality - Diabetes Care, Job#00392422 | Roche Diagnostics | Indianapolis, IN |
| Vice President, Medical Affairs | Regenesis Biomedical, Inc. | Scottsdale, AZ |
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