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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

Likvor receives first order for Likvor CELDA system from Aalborg Hospital, North Denmark Region

LinkMed’s portfolio company Likvor has received its first order for the Likvor CELDA™ system from a customer outside Sweden. The order comes from Aalborg Hospital which is the largest hospital in the North Denmark Region.

8 Mar 2010

Necessity of repeat biopsy in suspected prostate cancer: Gen-Probe's PROGENSA PCA3 assay can help determine

Gen-Probe's PROGENSA® PCA3 assay can help determine whether men suspected of having prostate cancer should undergo a repeat biopsy, according to data from the two largest studies to date of the molecular urine test. The studies were presented last week at the American Society of Clinical Oncology's (ASCO) Genitourinary (GU) Cancers Symposium in San Francisco.

8 Mar 2010

Sigma Life Science extends portfolio of knockout rat models with the release of ADME/Tox applications

Sigma® Life Science, an innovative brand of Sigma-Aldrich®, today extended its portfolio of knockout rat models with the announcement of a new suite of models designed to facilitate more predictive absorption, distribution, metabolism, excretion and toxicity (ADME/Tox) studies.

8 Mar 2010

Engineers develop Active Handrest device to help people perform precision tasks with hands

University of Utah engineers developed a computer-controlled, motorized hand and arm support that will let doctors, artists and others precisely control scalpels, brushes and tools over a wider area than otherwise possible, and with less fatigue.

8 Mar 2010

Core Essence Orthopaedics to showcase advances in implant technology at 2010 Hand Surgery Symposium

Core Essence Orthopaedics, Inc., an innovative medical device company focused on minimally invasive soft tissue and skeletal repair solutions (for the extremities), will be attending the 12th Annual Hand Surgery Symposium in Philadelphia.

8 Mar 2010

Scientists devise software algorithm to detect medically useful information from whole-blood samples

Scientists at the Stanford University School of Medicine have devised a software algorithm that could enable a common laboratory device to virtually separate a whole-blood sample into its different cell types and detect medically important gene-activity changes specific to any one of those cell types.

8 Mar 2010

Engineers built sensor array that can detect single molecules of hydrogen peroxide

MIT chemical engineers have built a sensor array that, for the first time, can detect single molecules of hydrogen peroxide emanating from a single living cell.

7 Mar 2010

Electromagnetic pulses decrease pain and inflammation associated with osteoarthritis of knee

Electromagnetic pulses significantly decrease pain and inflammation associated with osteoarthritis of the knee, according to Henry Ford Hospital researchers.

7 Mar 2010

Healthy communication between patients and physicians reduces medical errors

National Patient Safety Awareness Week is taking place from March 7th to the 13th. This year’s theme is all about healthy communication between patients and their physicians. The simple theme Let’s Talk: Healthy Conversations for Safer Healthcare is aimed at helping people become more involved in their own health care.

6 Mar 2010

Leadership challenges and best practices in dealing with FDA’s REMS

Three pharmaceutical executives with extensive experience in dealing with the FDA’s Risk Evaluation and Mitigation Strategy (REMS) will share their thoughts and practices at an open industry webinar at 12 noon EST on Wednesday, March 10, sponsored by ParagonRx.

6 Mar 2010

Device / Technology News

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

Likvor receives first order for Likvor CELDA system from Aalborg Hospital, North Denmark Region

Necessity of repeat biopsy in suspected prostate cancer: Gen-Probe's PROGENSA PCA3 assay can help determine

Sigma Life Science extends portfolio of knockout rat models with the release of ADME/Tox applications

Engineers develop Active Handrest device to help people perform precision tasks with hands

Core Essence Orthopaedics to showcase advances in implant technology at 2010 Hand Surgery Symposium

Scientists devise software algorithm to detect medically useful information from whole-blood samples

Engineers built sensor array that can detect single molecules of hydrogen peroxide

Electromagnetic pulses decrease pain and inflammation associated with osteoarthritis of knee

Healthy communication between patients and physicians reduces medical errors

Leadership challenges and best practices in dealing with FDA’s REMS

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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