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Rcadia Medical Imaging receives CE Mark for COR Analyzer System

Rcadia Medical Imaging today announced that it has received a CE Mark for the COR Analyzer® System, its proprietary software that helps identify patients with significant CAD (Coronary Artery Disease) by a fully automatic analysis of coronary CT angiography (cCTA) studies. The CE Mark allows the company to market the system in the European Union and other countries that accept the CE Mark registration. The COR Analyzer is marketed in the U.S. under 510(k) clearance and Rcadia was named 2009 Best New Radiology Vendor by AuntMinnie.com.

8 Mar 2010

invendo medical seeks premarket clearance for new C20 colonoscopy system

invendo medical announced today that the company has filed its 510(k) notice submission with the Food and Drug Administration for premarket clearance of the company's new C20™ colonoscopy system including the SC20™ single-use colonoscope. This is the first FDA submission for invendo medical in the United States.

8 Mar 2010

Replication Medical receives CE mark for GelFix Posterior Spinal Distraction implant

Replication Medical, Inc., a developer of proprietary, hydrogel based products for the spine and other surgical applications, announced today that it has received a CE mark for its GelFix Posterior Spinal Distraction implant. A CE mark is the quality assurance certification requirement recognized by members of the European Union for sales into those countries.

8 Mar 2010

biospace med receives FDA 510(k) clearance for sterEOS 2D/3D workstation for pediatric use in spine applications

biospace med announced today that it has received 510(k) clearance from the FDA to market the Company’s sterEOS 2D/3D workstation for pediatric use in spine applications. The Company’s EOS ultra-low-dose imager previously has been FDA-cleared for use in pediatrics and adults, while sterEOS has previously been FDA-cleared for adult use in spine.

8 Mar 2010

SensAble Technologies' digital dentistry product line receives $8M infusion

SensAble Technologies, Inc®, a leading provider of 3D modeling software, haptic devices and dental restoration design and fabrication solutions, announced that it has received an $8 million investment to propel sales, marketing and engineering efforts for its digital dentistry product line. Existing investor HLM Venture Partners led the round and was joined by North Bridge Venture Partners, both of whom are headquartered in the Boston area, and have extensive expertise with medical device company funding.

8 Mar 2010

iCAD granted patent covering SecondLook Digital CAD solution incorporating lesion metrics

iCAD, Inc., an industry-leading provider of advanced image analysis and workflow solutions for the early identification of cancer, announces that the United States Patent and Trademark Office recently granted the company Patent Number 7,660,448. This patent covers future iterations of iCAD’s SecondLook® Digital Computer-Aided Detection (CAD) solution with potential application to the company’s other image analysis solutions.

8 Mar 2010

Fluidigm's Access Array System: New 5kb and 10kb long-range PCR protocols introduced

Fluidigm Corporation today announced the release of 5kb and 10kb long-range PCR protocols for its Access Array™ System. Researchers interested in targeted re-sequencing projects for large cohort studies can use these new protocols and the Fluidigm Access Array System to amplify up to 48 samples per array. Long-range PCR enables new applications on the Access Array System by allowing researchers to enrich significantly more sequence per sample.

8 Mar 2010

Butler Health System to implement Alpha Systems' enterprise EDM solution

Alpha Systems, a premier provider of electronic data and document management solutions, today announced that Butler Health System (Butler), an innovative healthcare provider located in Pennsylvania, has named Alpha Systems their vendor of choice for enterprise electronic document management (EDM) software. This move is designed to improve Butler’s communication across the enterprise while moving the healthcare provider closer to a paperless environment.

8 Mar 2010

Ascension Orthopedics launches PyroTITAN Humeral Resurfacing Arthroplasty System

Ascension Orthopedics, Inc., a leader in orthopedic extremity implants, announces the international market launch of the PyroTITAN™ Humeral Resurfacing Arthroplasty System at the American Academy of Orthopaedic Surgeons Annual Conference in New Orleans, LA, March 9-13, 2010. Designed to meet the unique soft tissue biocompatibility requirements of the shoulder joint, the PyroTITAN humeral resurfacing implant is the first commercially-available, human shoulder arthroplasty prosthesis made of PyroCarbon.

8 Mar 2010

Luminetx, Alliance Medical sign exclusive national sales distribution agreement

Luminetx®, a division of Christie Medical Holdings, Inc. and recently acquired by Christie Digital Systems USA, Inc., has signed an exclusive national sales distribution agreement with New Alliance of Independent Medical Distributors, Inc., DBA Alliance Medical. The agreement, effective last month, aligns the medical device company with Alliance Medical, the nation’s largest consortium of specialty medical sales distribution companies for intravenous devices, with comprehensive access to the U.S. acute, oncology and home health markets.

8 Mar 2010

ThermalTherapeutic Systems receives FDA clearance for VERATHERM Portable Hyperthermic Perfusion System

ThermalTherapeutic Systems, Inc. today announced that the FDA has cleared the company to market its VERATHERM™ Portable Hyperthermic Perfusion System effective immediately.

8 Mar 2010

GeneGo's industry-FDA MetaTox partnership program: Tools and contents released

GeneGo announces the release of the first set of tools and content to come out of its industry-FDA MetaTox™ partnership program. The MetaTox partnership is developing a unique comprehensive systems toxicology suite designed for compound safety assessment in chemical and pharmaceutical R&D.

8 Mar 2010

Osteotech's MagniFuse Bone Graft generates $1M in revenue

Osteotech, Inc., a leader in the emerging field of biologic products for regenerative healing, announced today that its MagniFuse™ Bone Graft has generated its first $1 million in revenue during the four month period beginning with the limited launch of the product in late October 2009. Osteotech began the first phase of its strategic limited launch of MagniFuse with the release of three procedure specific forms for posterior cervical and posterolateral spine fusion and spinal deformity procedures.

8 Mar 2010

mtm laboratories launches CINtec PLUS screening system for cervical cancer

mtm laboratories, a privately held diagnostics company today announced the launch of CINtec® PLUS, the company’s next generation cervical cancer screening product with unmatched accuracy for the screening and management for cervical cancer. CINtec® PLUS will be launched with claims direct in Germany, Italy, Spain, France and the UK, and will also be available in other parts of the world via mtm’s nominated distributors.

8 Mar 2010

Evaluating asymptomatic diabetics for CHD: Speckle Tracking by Echo ultrasound substudy sponsored

Cardiovascular death is the most common cause of mortality among Type 2 diabetics and claims the lives of millions each year, with many diabetics experiencing their first “symptom” as a heart attack or sudden death. Understanding that diabetics are at high risk for Coronary Heart Disease (CHD) and that many with the disease are asymptomatic, Toshiba America Medical Systems, Inc., has sponsored Speckle Tracking by Echo, a faCTor64 substudy using Toshiba’s Wall Motion Tracking ultrasound technology.

8 Mar 2010

DiagnoCure: Global studies confirm clinical utility of PROGENSA PCA3 test

DiagnoCure, Inc., a life sciences company commercializing high-value cancer diagnostic tests and delivering laboratory services, announced that the clinical utility of the PROGENSA(R) PCA3 test, developed and commercialized by its partner Gen-Probe, was confirmed in two large worldwide studies, conducted in a subset of patients in GlaxoSmithKline's REDUCE trial of dutasteride. The results demonstrate that PCA3 can help determine whether men suspected of having prostate cancer should undergo a repeat biopsy and can predict the risk of having an aggressive cancer.

8 Mar 2010

KCI receives reimbursement approval for use of V.A.C. ATS Therapy System in Japan

Kinetic Concepts, Inc. today announced it has received reimbursement approval from Japan’s Health Insurance Bureau for use of the innovative V.A.C. ATS® Therapy System in the country. The approval signifies an important advancement in the company’s plans for market launch in April and follows Japan’s Ministry of Health, Labor and Welfare’s decision in November 2009 to grant final regulatory approval for the product.

8 Mar 2010

UTSA celebrates grand opening of NVI facility in the greater San Antonio region

The University of Texas at San Antonio celebrates the grand opening of its New Venture Incubator, a facility with laboratory, office and meeting spaces to support technology start-ups in the greater San Antonio region. The incubator, housed on UTSA’s Main Campus, will serve as a bridge between San Antonio entrepreneurs and the region’s research and development community.

8 Mar 2010

Chinmax Medical Systems files complaint against Inverness Medical Beijing over distribution rights for Biosite products

On January 28, 2010, Chinmax Medical Systems, Inc., a leading distributor of clinical diagnostics in China, filed a civil complaint in the People's Court of Yangpu District, Shanghai against Inverness Medical Beijing Co. Ltd., a subsidiary of Inverness Medical Innovations, Inc..

8 Mar 2010

Entelos, RegeneMed release iToxFX to screen novel compounds for potential toxicity issues

Entelos, Inc., a simulation and modeling company focused on human health, and RegeneMed, Inc., a tissue-based drug discovery and regenerative medicine company, announced today the release of iToxFX™.

8 Mar 2010

Device / Technology News

Rcadia Medical Imaging receives CE Mark for COR Analyzer System

invendo medical seeks premarket clearance for new C20 colonoscopy system

Replication Medical receives CE mark for GelFix Posterior Spinal Distraction implant

biospace med receives FDA 510(k) clearance for sterEOS 2D/3D workstation for pediatric use in spine applications

SensAble Technologies' digital dentistry product line receives $8M infusion

iCAD granted patent covering SecondLook Digital CAD solution incorporating lesion metrics

Fluidigm's Access Array System: New 5kb and 10kb long-range PCR protocols introduced

Butler Health System to implement Alpha Systems' enterprise EDM solution

Ascension Orthopedics launches PyroTITAN Humeral Resurfacing Arthroplasty System

Luminetx, Alliance Medical sign exclusive national sales distribution agreement

ThermalTherapeutic Systems receives FDA clearance for VERATHERM Portable Hyperthermic Perfusion System

GeneGo's industry-FDA MetaTox partnership program: Tools and contents released

Osteotech's MagniFuse Bone Graft generates $1M in revenue

mtm laboratories launches CINtec PLUS screening system for cervical cancer

Evaluating asymptomatic diabetics for CHD: Speckle Tracking by Echo ultrasound substudy sponsored

DiagnoCure: Global studies confirm clinical utility of PROGENSA PCA3 test

KCI receives reimbursement approval for use of V.A.C. ATS Therapy System in Japan

UTSA celebrates grand opening of NVI facility in the greater San Antonio region

Chinmax Medical Systems files complaint against Inverness Medical Beijing over distribution rights for Biosite products

Entelos, RegeneMed release iToxFX to screen novel compounds for potential toxicity issues

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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