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| AdvaMed SmartBrief |
| April 27, 2012 |
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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)
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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)
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.com (free registration) (4/26)
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. American City Business Journals/St. Louis (4/25)
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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. MedCityNews.com (4/26)
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)
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)
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. HealthImaging.com (4/30)
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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.com (Boston) (4/25)
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)
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. Blank (3/27)
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. Blank (3/27)
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