<% ADLIST_MEGA section={"sectionId":"TOPBANNER","pickFromSponsorship":true,"pickFromHorizontal":true} section={"sectionId":"NEWS1","pickFromSponsorship":true,"pickFromHorizontal":true} section={"sectionId":"NEWS2","pickFromSponsorship":true,"pickFromHorizontal":true} section={"sectionId":"NEWS3","pickFromSponsorship":true,"pickFromHorizontal":true} section={"sectionId":"NEWS4","pickFromSponsorship":true,"pickFromHorizontal":true} section={"sectionId":"NEWS5","pickFromSponsorship":true,"pickFromHorizontal":true} section={"sectionId":"NEWS6","pickFromSponsorship":false,"pickFromHorizontal":false} section={"sectionId":"FEATUREDCONTENT","pickFromSponsorship":true,"pickFromHorizontal":true} issueId=8DDB128C-72F9-4302-8896-E78F105DF92F%>
Seattle mobility device maker takes in $1.1M in funding round | Elekta's relocation plan could add about 100 jobs in Atlanta | Chief operating officer of Synergetics to step down
<% ADLIST_BEGIN %> #8A2981 16px Helvetica bold color:#8A2981; font-size:16px; font-family:Helvetica; font-weight:bold; text-decoration:none; line-height:20px; display: block; #000000 14px Helvetica normal font-family:Helvetica; font-size:14px; color:#000000; line-height: 20px; <% ADLIST_END sectionId=TOPBANNER %>
April 27, 2012
ADVAMED SmartBrief
News for medical technology professionals
SIGN UP ⋅   FORWARD
Top Story
HeartWare's cardiac pump gains support of FDA panel
A panel of FDA advisers voted in favor of approving the HeartWare ventricular assist device, a blood pump tailored for use in severe heart failure patients awaiting transplants. The panel concluded that the device was helpful in saving lives, but urged HeartWare to run additional safety studies if it obtains FDA approval.
Reuters (4/26) 
LinkedIn Twitter Facebook Google+ Email
Orthofix Sheds Sports Medicine Unit to WSHP for $157 Million
Orthofix (Lewisville, TX) is narrowing its focus and concentrating more on its spine and orthopedics space with the news of it divesting its sports medicine business unit Breg (Carlsbad, CA). Breg provides bracing and cold therapy products to treat sports-related conditions. Find out the details.
Sponsored Content
Business & Market Trends
Seattle mobility device maker takes in $1.1M in funding round
Cadence Biomedical has obtained $1.1 million in a round of financing headed by HealthTech Capital. The Seattle company will use the funding to finance the development and marketing of its Kickstart Kinetic Orthosis system, a batteryless device targeted for use by people with walking disabilities or weakened muscles.
GeekWire (4/26) 
LinkedIn Twitter Facebook Google+ Email
Elekta's relocation plan could add about 100 jobs in Atlanta
Elekta, which specializes in oncology products, is transferring its North American base to the Central Perimeter business district in Atlanta. The move is expected to generate more than 100 life sciences jobs in the area in the next five years.
AuntMinnie (free registration) (4/26) 
LinkedIn Twitter Facebook Google+ Email
Chief operating officer of Synergetics to step down
Kurt Gampp Jr. is resigning as chief operating officer and executive vice president at Synergetics, effective May 4. The O?Fallon, Mo.-based company specializes in microsurgical tools for neurosurgical and ophthalmic uses.
The Business Journals (tiered subscription model)/St. Louis (4/25) 
LinkedIn Twitter Facebook Google+ Email
 
Effective Post-Market Clinical Follow-Up
Post-market surveillance including clinical follow-up, complaints, and vigilance are vital in ensuring compliance with the EU medical device directives, and are an essential component of a 13485 Quality Management System. Learn more about PMS and Vigilance. Visit the PMS Spotlight
Advertisement
<% ADLIST_BEGIN %>
International Developments
[[ logo ]]
International Developments
<% ADLIST_END sectionId=NEWS1 ISLOGO %>
<% ADLIST_BEGIN %><% ADLIST_END sectionId=NEWS1 MEDIUM_RECTANGLE %>
EndoSphere obtains EU approval for anti-obesity device
EndoSphere has earned CE Mark approval to market an incisionless anti-obesity device, called Satisphere, in Europe. The device, which is implanted in the small intestine via an endoscope, is designed to help patients shed excess weight without the need for drugs or surgery.
MedCity News (4/26) 
LinkedIn Twitter Facebook Google+ Email
<% ADLIST_BEGIN %> #8A2981 16px Helvetica bold color:#8A2981; font-size:16px; font-family:Helvetica; font-weight:bold; text-decoration:none; line-height:20px; display: block; #000000 14px Helvetica normal font-family:Helvetica; font-size:14px; color:#000000; line-height: 20px; <% ADLIST_END sectionId=NEWS1 %>
<% ADLIST_BEGIN %>
.
[[ fcSectionHeader ]]
[[ subHeader ]]
[[ logo ]]
[[ fcSectionHeader ]]
[[ subHeader ]]
LinkedIn Twitter Facebook Google+ 
LinkedIn Twitter Facebook Google+ 
263A5F36-6763-46C7-B399-4428C3A9FD06 8DDB128C-72F9-4302-8896-E78F105DF92F #8A2981 16px Helvetica bold color:#8A2981; font-size:16px; font-family:Helvetica; font-weight:bold; text-decoration:none; line-height:20px; display: block; #000000 14px Helvetica normal font-family:Helvetica; font-size:14px; color:#000000; line-height: 20px; padding-left:15px; padding-right:15px; 14px
Click here to learn more about Featured Content
<% ADLIST_END sectionId=FEATUREDCONTENT %>
<% ADLIST_BEGIN %>
Science & Health
[[ logo ]]
Science & Health
<% ADLIST_END sectionId=NEWS2 ISLOGO %>
<% ADLIST_BEGIN %><% ADLIST_END sectionId=NEWS2 MEDIUM_RECTANGLE %>
Microfluidic device extracts cancer cells from blood samples
Researchers from Harvard University and Children's Hospital Boston have developed a device for extracting circulating tumor cells from blood, and the device has potential applications in collecting stem cells. Tests on mice showed the microfluidic device can catch more than 90% of the cancerous cells and keep them intact for culturing, according to findings published in the journal Lab on a Chip.
CNET/Cutting Edge blog (4/25) 
LinkedIn Twitter Facebook Google+ Email
Technique detects genes linked to chronic myelogenous leukemia
Researchers have developed a DNA-based sensor that identifies defective genes that play a role in chronic myelogenous leukemia development. "This technique may be useful as an additional diagnostic and monitoring device for CML detection," according to the lead researcher. The study was published in the journal Analytical Chemistry.
Nature (4/25) 
LinkedIn Twitter Facebook Google+ Email
<% ADLIST_BEGIN %> #8A2981 16px Helvetica bold color:#8A2981; font-size:16px; font-family:Helvetica; font-weight:bold; text-decoration:none; line-height:20px; display: block; #000000 14px Helvetica normal font-family:Helvetica; font-size:14px; color:#000000; line-height: 20px; <% ADLIST_END sectionId=NEWS2 %>
<% ADLIST_BEGIN %>
Emerging Technologies
[[ logo ]]
Emerging Technologies
<% ADLIST_END sectionId=NEWS3 ISLOGO %>
<% ADLIST_BEGIN %><% ADLIST_END sectionId=NEWS3 MEDIUM_RECTANGLE %>
Latest version of GE's cardiovascular ultrasound wins FDA nod
GE Healthcare has received FDA clearance for Vivid E9 Breakthrough 2012, the latest version of its cardiovascular ultrasound device. The newly approved product, which features a 4D transducer, is designed for use in transeophageal echocardiography, mitral valve repair and related procedures.
Health Imaging online (4/30) 
LinkedIn Twitter Facebook Google+ Email
<% ADLIST_BEGIN %> #8A2981 16px Helvetica bold color:#8A2981; font-size:16px; font-family:Helvetica; font-weight:bold; text-decoration:none; line-height:20px; display: block; #000000 14px Helvetica normal font-family:Helvetica; font-size:14px; color:#000000; line-height: 20px; <% ADLIST_END sectionId=NEWS3 %>
<% ADLIST_BEGIN %>
.
Business Tips and Advice
Sponsored Content from American Express
[[ logo ]]
Business Tips and Advice
Sponsored Content from American Express
<% ADLIST_END sectionId=NEWS4 ISLOGO %>
<% ADLIST_BEGIN %><% ADLIST_END sectionId=NEWS4 MEDIUM_RECTANGLE %> <% ADLIST_BEGIN %> #8A2981 16px Helvetica bold color:#8A2981; font-size:16px; font-family:Helvetica; font-weight:bold; text-decoration:none; line-height:20px; display: block; #000000 14px Helvetica normal font-family:Helvetica; font-size:14px; color:#000000; line-height: 20px; <% ADLIST_END sectionId=NEWS4 %>
<% ADLIST_BEGIN %>
Government & Regulatory
[[ logo ]]
Government & Regulatory
<% ADLIST_END sectionId=NEWS5 ISLOGO %>
<% ADLIST_BEGIN %><% ADLIST_END sectionId=NEWS5 MEDIUM_RECTANGLE %>
Bill seeking stronger FDA oversight of medical devices advances
A Senate panel on Wednesday cleared a bill that would allow the FDA to evaluate the safety of approved medical devices and give conditional approvals dependent on further studies, among other provisions.
MassDevice (Boston) (4/25) 
LinkedIn Twitter Facebook Google+ Email
FDA approves advanced laser sheath from Spectranetics
The FDA has given Spectranetics approval for its next-generation GlideLight Laser Sheath. The device allows more accurate control and less force for safer extraction of cardiac leads.
Reuters (4/25) 
LinkedIn Twitter Facebook Google+ Email
<% ADLIST_BEGIN %> #8A2981 16px Helvetica bold color:#8A2981; font-size:16px; font-family:Helvetica; font-weight:bold; text-decoration:none; line-height:20px; display: block; #000000 14px Helvetica normal font-family:Helvetica; font-size:14px; color:#000000; line-height: 20px; <% ADLIST_END sectionId=NEWS5 %>
AdvaMed Events and Education
Supplier Controls: Regulations and Best Practices Virtual Meeting
Wednesday, June 6
Virtual Conference, 10:00 a.m. - 4:00 p.m. EST
Recent enforcement actions and several product-related tragedies highlight the risks of inadequate vendor selection and oversight, poor communication, misunderstanding of regulations and responsibilities, and a failure to apply the same risk-based approach to supplied components and services that one applies to one's own products and processes. This virtual conference brings together leading authorities from the FDA, industry and critical component suppliers to discuss strategies and best practices for instituting and maintaining a robust and responsible supplier control program. Visit MTLI online for more information.
LinkedIn Twitter Facebook Google+ Email
Diagnostics Submissions Workshop
Tuesday, June 12 – Wednesday, June 13
L'Enfant Plaza Hotel, Washington, D.C.
Get guidance from industry and government speakers on key diagnostics issues in an interactive day-and-a-half program. You will participate in sessions ranging from a current diagnostics overview, what it takes to create a quality 510(k) and PMA submission, CLIA waivers, tips and strategies for submissions, and interactive industry case studies. Through educational sessions and hands-on training, network and learn from your peers about these key focus areas in diagnostics. Visit MTLI online for more information.
LinkedIn Twitter Facebook Google+ Email
Learn more about AdvaMed:
About AdvaMed | Join | Courses | Events | Newsroom
JOBS
powered by
Principal Regulatory Affairs Specialist-Endo-Santa Rosa CA
MEDTRONIC - Santa Rosa, CA
R&D Technical Project Manager
ENDOLOGIX, INC. - Irvine, CA
Post Market Surveillance Regulatory Specialist
W.L. GORE - Phoenix, AZ
Regulatory Affairs Professional
W.L. GORE - Flagstaff, AZ
Director Global Marketing -- Core Brand Management
COVIDIEN - New Haven, CT
Regulatory Affairs Professional
W.L. GORE - Flagstaff, AZ
Regulatory Affairs Professional
W.L. GORE - Flagstaff, AZ
Sr. Quality Engineer - New Product Development
ENDOLOGIX, INC. - Irvine, CA
Regulatory Affairs Professional ? Venous/Access
W.L. GORE - Flagstaff, AZ
Regional Sales Director
REGENESIS BIOMEDICAL, INC. - Home based office, CA
Manager, Regulatory Affairs - 1 of 2
JOHNSON & JOHNSON - Fremont, CA
Senior Corporate Counsel
COVIDIEN - New Haven, CT
Manager, Sales Strategy - Transcatheter Heart Valve - 001277
EDWARDS LIFESCIENCES - Irvine, CA
Public Affairs Coordinator
ADVAMED - Washington, DC
Regulatory Affairs, Project Manager - Cardiac Surgery Systems- 001280
EDWARDS LIFESCIENCES - Salt Lake City, UT
Senior Analyst, CAD - 000614
EDWARDS LIFESCIENCES - Irvine, CA
Senior Quality Manager -Transcatheter Heart Valve - 001190
EDWARDS LIFESCIENCES - Irvine, CA
Director, Marketing
ENDOLOGIX, INC. - Irvine, CA
Vice President ? Research, Payment and Health Care Delivery Policy
ADVAMED - Washington, DC
Project Manager, Supplier Development - Transcatheter Heart Valve - 001303
EDWARDS LIFESCIENCES - Irvine, CA
Regulatory Affairs Manager
JOHNSON & JOHNSON  - Irwindale, CA
Senior Regulatory Affairs Manager with PMA Experience
COCHLEAR LIMITED - Centennial, CO
Senior Program Manager - Critical Care - 001311
EDWARDS LIFESCIENCES - Irvine, CA
<% ADLIST_BEGIN %>
SmartQuote
[[ logo ]]
<% ADLIST_END sectionId=NEWS6 ISLOGO %>
<% ADLIST_BEGIN %><% ADLIST_END sectionId=NEWS6 MEDIUM_RECTANGLE %>
  
  
Ideas are like rabbits. You get a couple and learn how to handle them, and pretty soon you have a dozen.
John Steinbeck,
American writer
LinkedIn Twitter Facebook Google+ Email
  
  
<% ADLIST_BEGIN %> #8A2981 16px Helvetica bold color:#8A2981; font-size:16px; font-family:Helvetica; font-weight:bold; text-decoration:none; line-height:20px; display: block; #000000 14px Helvetica normal font-family:Helvetica; font-size:14px; color:#000000; line-height: 20px; <% ADLIST_END sectionId=NEWS6 %>
Sign Up
SmartBrief offers 200+ newsletters
Advertise
Learn more about the SmartBrief audience
Subscriber Tools:
Contact Us:
Advertising  -  Wynn Hansen
P: 202.470.1149
Jobs Contact  -  jobhelp@smartbrief.com
Editor  -  Lisa Gough
Mailing Address:
SmartBrief, Inc.®, 555 11th ST NW, Suite 600, Washington, DC 20004
© 1999-2017 SmartBrief, Inc.®
Privacy policy |  Legal Information