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Saturday, November 21, 2009 6:53 AM

CE Mark

Type: Organization

Name: CE Mark

First Reported 17 hours ago - Updated 45 mins ago - 10 Documents

Boston Scientific Corporation

Boston Scientific gets FDA clearance, CE Mark for WallFlex Fully Covered Esophageal Stent

- US medical devices maker Boston Scientific Corporation (NYSE: BSX) said today it has received 510(k) clearance from the US Food and Drug Administration (FDA) and CE Mark approval to market its WallFlex Fully Covered Esophageal Stent for the treatment ... [Pharmacy Choice - 45 mins ago]

Entities: Stent, esophageal, CE Mark, Boston Scientific Corporation, Food and Drug Administration

First Reported 11/19/2009 - Updated 11/19/2009 - 5 Documents

Anika Therapeutics, Inc.

Anika Therapeutics' "ELEVESS Light" receives European CE Mark approval

Anika Therapeutics, Inc. (Nasdaq: ANIK), a leader in products for tissue protection, healing and repair based on hyaluronic acid (“HA”) technology, today announced that it has received European CE Mark approval for “ELEVESS™ Light,” the Company’s latest ... [News-Medical.Net - 11/19/2009]

Entities: Anika Therapeutics, Inc., CE Mark, Dermatology, Hyaluronic Acid

First Reported 11/19/2009 - Updated 11/19/2009 - 1 Documents (in Medicine)

CleveMed Receives ISO 13485, CE Mark, Canadian Certificate Approval

CLEVELAND--(BUSINESS WIRE)--CleveMed recently received ISO 13485 certification issued by BSI Management Systems America Inc., one of the foremost auditing bodies in the world. CleveMed has also received the CE Mark and CMDCAS allowing its products to ... [Business Wire - 11/19/2009]

Entities: CE Mark, International Organization for Standardization, Rehabilitation, Cleveland (Ohio, United States)

First Reported 11/19/2009 - Updated 11/19/2009 - 1 Documents

CleveMed to distribute its products in Europe and Canada following receipt of the CE Mark and CMDCAS

CleveMed recently received ISO 13485 certification issued by BSI Management Systems America Inc., one of the foremost auditing bodies in the world. CleveMed has also received the CE Mark and CMDCAS allowing its products to be distributed to the large ... [News-Medical.Net - 11/19/2009]

Entities: CE Mark, Canada, Parkinson's Disease, International Organization for Standardization

First Reported 11/19/2009 - Updated 11/19/2009 - 1 Documents

CleveMed Receives CE Mark, Canadian Certificate Approval

CleveMed has … received the CE Mark and CMDCAS allowing its products to be distributed to the large European and the Canadian markets which willstrengthen its worldwide market presence. ... [FDA News - 11/19/2009]

Entities: CE Mark

First Reported 22 hours ago - Updated 22 hours ago - 1 Documents

LED lighting power modules accept up to 305VAC

Power Partners has introduced the PIL100 series of 100W LED lighting power modules in response to demand for higher-power, high-efficiency lighting solutions.The PIL100 series is available in a choice of constant current or constant voltage models.All ... [Electronics Talk - 22 hours ago]

Entities: CE Mark

First Reported 5 hours ago - Updated 5 hours ago - 1 Documents

NEC Corporation

Fair Trade

OSHA evaluates product safety compliance mechanisms in the interest of U.S.-European trade agreementsFor the second time since 2005, the Occupational Safety and Health Administration (OSHA) is considering a proposal permitting the use of a Supplier's ... [Electrical Construction And Maintenance - 5 hours ago]

Entities: CE Mark, NEC Corporation, United States

First Reported 11/19/2009 - Updated 11/19/2009 - 1 Documents (in Health)

Delcath Systems Reports Substantial Progress Recent Follow-On Public Offering Provides Resources to Execute PlanActive Negotiations with Potential In

"Since we last communicated with our shareholders in late July, our team has achieved many significant milestones as we move into the first regulatory reviews for our PHP System and strive towards European commercialization in 2010," said Eamonn P. Hobbs, ... [Yahoo! Canada - 11/19/2009]

Entities: Delcath Systems Incorporated, melphalan, Food and Drug Administration, CE Mark, clinical study

First Reported 11/17/2009 - Updated 11/17/2009 - 2 Documents (in Biology)

Ellipse Technologies' MAGEC Technology for spinal deformity treatment receives CE Mark

Ellipse Technologies, Inc. (“Ellipse”) announced today it has received CE Mark (Conformité Européenne) for its MAGECTM Technology for the treatment of spinal deformity. The first application for this technology is for the treatment of spinal scoliosis ... [News-Medical.Net - 11/17/2009]

Entities: CE Mark, Malformation, Michael Henson, Ellipse

First Reported 11/17/2009 - Updated 11/17/2009 - 1 Documents (in Internet & IT)

EU approves EDDA's liver imaging software

EDDA Technology has received CE Mark approval from European regulators for its IQQA-Liver software, designed to help doctors in planning for liver transplantation and tumor resection procedure in patients. The application, which is already approved by ... [SmartBrief - 11/17/2009]

Entities: European Union, CE Mark, hepatic

First Reported 11/18/2009 - Updated 11/18/2009 - 1 Documents (in Biology)

Quest Diagnostics' Simplexa Influenza A H1N1 (2009) test receives CE mark

Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced that the Simplexa Influenza A H1N1 (2009) test developed by its Focus Diagnostics business has been CE marked and ... [News-Medical.Net - 11/18/2009]

Entities: Influenza A H1N1 Virus, Quest Diagnostics Incorporated, CE Mark, Virus

First Reported 11/18/2009 - Updated 11/18/2009 - 1 Documents

Solta Medical Announces European Launch Of Fraxel Re:store Dual Laser System - Quick Facts

(RTTNews) - Solta Medical, Inc. (SLTM: News ) on Wednesday announced its European launch of the Fraxel re:store Dual laser system with the recent CE Mark approval.The new Fraxel re:store Dual system is optimized for both facial procedures and large body ... [RTTNews.com - 11/18/2009]

Entities: Laser, CE Mark, Wavelength

Quotes

Furthermore, a recent article in Transfusion (vol 49, August 2009 supplement) entitled "Emerging infectious disease agents and their potential threat to transfusion Safety" highlighted vCJD as a 'red category agent' - i e. the highest priority with regard to risk level...

SaBTO Recommends Use of ProMetic Life Sciences Inc. (PFSCF.PK)'s P-Capt(R) Prion Reduction Filter ... [BioSpace - 6 hours ago]

...in our Phase III clinical study completed, we are now beginning to prepare our application to the FDA for marketing approval," said Mr. Hobbs. "We continue to expect that we will submit the application to the FDA by the end of the first half of 2010. Meanwhile, we are optimistic about our ability to gain CE mark approval in Europe in early 2010 and expect to begin commercial sales in the European markets shortly thereafter. With the proceeds from the offering boosting our cash balance to more than $37 million, and the potential opportunity to gain additional resources through international partnerships, we are very well positioned to execute on our strategies, expand the potential benefits of the PHP System to patients globally and build increasing returns to our shareholders."

Delcath Systems Reports Substantial Progress Recent Follow-On Public Offering Provides Resources ... [Yahoo! Canada - 11/19/2009]

...and other geographies that provide approvals based on the CE mark," said Charles H Sherwood, Ph D , Anika's President and Chief Executive Officer. "Domestically, we are in discussions with the FDA about the pathway for approval for this new fine-line product."

Anika Therapeutics (ANIK) Received European CE Mark for Aesthetic 'ELEVESS Light' [Street Insider - 11/19/2009]

Terry Bolsher, Centrum Pile managing director, says the investment is designed to ready the company for a return to house building. "This is a major and significant investment for us, especially at a time when the construction industry, and the piling and foundations sector in particular, is going through such a deep recession" he says. 'However, this considerable expansion is for the long term and I am confident that we will be able to take advantage of the upturn when it comes...

Aarsleff lays foundations for sludge treatment [Contract Journal - 11/16/2009]

More Content

sort by: Date \| Relevance
Boston Scientific gets FDA clearance, CE Mark f... [Pharmacy Choice - 45 mins ago]
Fair Trade [Electrical Construction And Maintenance - 5 hours ago]
SaBTO Recommends Use of ProMetic Life Sciences ... [BioSpace - 6 hours ago]
WallFlex Esophageal Stent Gets FDA OK, CE Mark [EndoNurse - 7 hours ago]
FDA Clearance and CE Mark for Boston Scientific... [ASM International - 15 hours ago]
BioMed News Bytes: AstraZeneca, Delcath, Unilife [Seeking Alpha - 15 hours ago]
Boston Scientific's WallFlex Fully Covered Esop... [News-Medical.Net - 16 hours ago]
Market Report -- In Play (BSX) [Briefing.com via MSN Money - 16 hours ago]
BRIEF-Boston Scientific announces FDA clearance... [Forbes.com - 16 hours ago]
BRIEF-Boston Scientific announces FDA clearance... [Interactive Investor International - 16 hours ago]
Boston Scientific Announces FDA Clearance and C... [Earthtimes.org - 16 hours ago]
Boston Scientific (BSX) Receives 510(k) Clearan... [Street Insider - 17 hours ago]
Boston Scientific Announces FDA Clearance and C... [PR Newswire via MSN Money - 17 hours ago]
LED lighting power modules accept up to 305VAC [Electronics Talk - 22 hours ago]
CleveMed Receives CE Mark, Canadian Certificate... [FDA News - 11/19/2009]
Surgeon 'glues' the breastbone together after o... [Science Daily - 11/19/2009]
CleveMed to distribute its products in Europe a... [News-Medical.Net - 11/19/2009]
BioMed News Bytes: AstraZeneca, Delcath, Unilif... [SocialPicks - 11/19/2009]
CTT's Pain Mangement Device Sales to Result in ... [Seeking Alpha - 11/19/2009]
CleveMed Receives ISO 13485, CE Mark, Canadian ... [Business Wire - 11/19/2009]
Anika Therapeutics' "ELEVESS Light" r... [News-Medical.Net - 11/19/2009]
Delcath Systems Reports Substantial Progress Re... [Yahoo! Canada - 11/19/2009]
Anika Therapeutics (ANIK) Received European CE ... [Street Insider - 11/19/2009]
Market Report -- In Play (ANIK) [Briefing.com via MSN Money - 11/19/2009]
Anika Therapeutics Receives European CE Mark Ap... [Business Wire UK - 11/19/2009]
Anika Therapeutics Receives European CE Mark Ap... [Business Wire via MSN Money - 11/19/2009]
Delcath Systems Reports Substantial Progress [Yahoo! Canada - 11/19/2009]
Solta Medical Announces European Launch Of Frax... [RTTNews.com - 11/18/2009]
Solta Medical Announces New Fraxel re:store(R) ... [PR Newswire via MSN Money - 11/18/2009]
Quest Diagnostics' Simplexa Influenza A H1N1 (2... [News-Medical.Net - 11/18/2009]

Blogs

sort by: Date \| Relevance
One small strip of plaster, one giant strip of ... [CNET News.com - 11/04/2009] A wireless digital 'plaster' that monitors vital signs is being tested on patients and volunteers at Imperial College London.(Credit: Toumaz Technology) When you ...
Unilife: Medical Device Innovator Creating Jobs... [Long Investment Ideas from Seeking Alpha - 10/30/2009] Mike Havrilla submits:Unilife Medical Solutions (UNIFF.PK) is an emerging medical device manufacturer with business segments that include pre-filled syringes for ...
Unilife: Medical Device Innovator Creating Jobs... [Healthcare Sector and Stocks Analysis from Seek ... - 10/30/2009] Mike Havrilla submits:Unilife Medical Solutions (UNIFF.PK) is an emerging medical device manufacturer with business segments that include pre-filled syringes for ...
Medical Device Trades: 7 Stocks Under 5 Bucks [Biotech Sector and Stocks Analysis from Seeking ... - 07/06/2009] Mike Havrilla submits:Below are extreme trades among companies with stock prices under $5 from the BioMedReports.com FDA Calendar, which includes 238 entries as ...
FDA Extreme Trades: 16 Stocks Under 5 Bucks [Healthcare Sector and Stocks Analysis from Seek ... - 06/28/2009] Mike Havrilla submits:Below are FDA extreme trades among 16 companies with stock prices under $5 from the BioMedReports.com FDA Calendar (database includes 225 entries ...

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