BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Medwave Inc. (MDWV) Announces Receipt of MDD CE Certification and Additional U.S. FDA 510(k) Clearance to Market Its Patented Microwave Coagulation/Ablation System and Devices


2/2/2009 7:20:26 AM

SAN DIEGO, Feb. 2 /PRNewswire/ -- MedWaves, Inc. announces the receipt of Medical Device Directive (MDD) CE Mark Certification. This is in addition to having already received U.S. FDA 510(k) clearance to market the Company's patented Microwave Coagulation/Ablation System for surgical applications. The system and single patient use devices enable surgeons and interventional radiologists to treat soft tissue problems, such as tumors, using microwave thermal ablation. The clearance sets the stage for rapid expansion of the Company's product portfolio and indications for use through additional U.S. FDA clearances. The Company's proprietary technology focuses on the development of minimally invasive devices in wide ranges of size, shape and flexibility intended to meet clinicians' requirements for treatment of tumors in bone, liver, lung and other locations.

MedWaves Microwave Coagulation/Ablation System overcomes limitations of existing microwave and radiofrequency (RF) thermal ablation technologies, the standard of treatment for cancerous tumor patients who are not candidates for resection surgery. For these patients, microwave ablation can be adjunctive or a replacement for the curative and/or palliative therapies of standard therapies, such as chemotherapy and/or radiation. It can be an option for patients where other thermal modalities are not possible due to tumor size, location or patient condition.

About the AveCureĀ® Ablation System and Devices:

-- FDA 510(k) clearances received for microwave coagulation/ablation system, which includes: Microwave power generator/controller, 14, 11 and 9 gauge probes

-- CE Mark certification received for microwave coagulation system, which includes: Microwave power generator/controller, 16, 14, 11 and 9 gauge probes

-- Only approved ablation system that provides physicians real-time temperature feedback and control

-- Proprietary efficient dynamic power delivery is capable of producing larger ablation zones relative to existing energy-based modalities

-- Pre-clinical results suggest ablation zone correlation to CT and ultrasound images

-- Disposable, single-use delivery devices provide valuable recurring revenue stream

-- Elegant single generator and single device design (cost savings and attractive improvement over marketed multi-generator, multi-device offerings)

-- Turnkey device platform presently poised for commercial launch

About MedWaves, Inc.

MedWaves, Inc. develops innovative and proprietary microwave ablation technology for the minimally invasive coagulation/ablation of soft tissues and tumors. The Company's management team has extensive experience in the medical device marketplace. MedWaves' clinical advisory board membership includes renowned surgeons from UCSD, City of Hope and The Cushier Skills Center. MedWaves, Inc. is located in San Diego, California, USA.

Contact information:

Ted Ormsby, President/CEO 16760 W Bernardo Drive San Diego, CA 92127 Tel: 858.946.0015 Email: tedormsby@avecure.com Website: http://www.medwaves.com

This release was issued through eReleases(TM). For more information, visit http://www.ereleases.com.

Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES