Device / Technology News

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LifeCell, Novadaq Technologies sign exclusive sales, marketing agreement

LifeCell Corporation, a business unit of Kinetic Concepts, Inc., and Novadaq Technologies Inc. announced today the signing of an exclusive sales and marketing agreement for distribution of Novadaq's SPY Imaging System in North American surgical markets. LifeCell will drive adoption for the SPY System in breast reconstructive, head and neck, and colorectal surgical specialties, with more than half a million procedures projected annually.

2 Sep 2010

InfraReDx receives 510(k) clearance to market LipiScan IVUS Coronary Imaging System

InfraReDx, Inc., a medical device company developing intelligent cardiovascular diagnostic imaging technologies, today announced that it has received 510(k) clearance from the United States Food and Drug Administration to market the LipiScan IVUS Coronary Imaging System. LipiScan IVUS is the first cardiac catheter to combine intravascular ultrasound and near-infrared spectroscopy to help cardiologists identify and characterize the plaques that complicate stenting and are associated with acute coronary events.

2 Sep 2010

GI Dynamics, Elemental Healthcare sign agreement for distribution of EndoBarrier Gastrointestinal Liner

GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, today announced it has entered into a new agreement with Elemental Healthcare, based in Hungerford, Berkshire, for the distribution of the EndoBarrier Gastrointestinal Liner in England, Wales, Scotland, Northern Ireland and Ireland.

2 Sep 2010

MIRACLE project to develop lab-on-chip system for diagnosing cancer

Today, at the Engineering in Medicine and Biology Conference in Buenos Aires (Argentina), imec and its project partners announce the launch of the European Seventh Framework Project MIRACLE. The MIRACLE project aims at developing an operational lab-on-chip for the isolation and detection of circulating and disseminated tumor cells in blood.

2 Sep 2010

Central Logic Core Web-based software application for bed management launched

Central Logic, the healthcare industry's leading provider of innovative patient flow software, today announced the development and introduction of Central Logic Core™, an innovative and intelligent Web-based software application for bed management. Core, which represents Central Logic's aggressive entrée into the bed management segment of the healthcare sector, can be used by healthcare facilities of all sizes, from small hospitals to the largest and most sophisticated systems.

2 Sep 2010

Leon-Berard Cancer Center to install CyberKnife VSI System

Accuray Incorporated, a global leader in the field of radiosurgery, today announced that the first CyberKnife VSI System to be installed in Europe was placed at the Leon-Berard Cancer Multidisciplinary Center in Lyon, France. The CyberKnife VSI System is the newest addition to the CyberKnife product family.

2 Sep 2010

First genetically engineered rat derived from rat ES cells developed with StemCells' technology

StemCells, Inc. announced today that its technology was recently used by independent researchers to achieve the first genetically engineered rat derived from rat embryonic stem (ES) cells. This breakthrough, published this month in the international peer-reviewed journal Nature, opens the door to the types of genetic manipulations previously only possible in mice, and paves the way for modeling a broader range of human diseases with the rat.

2 Sep 2010

Abbott RealTime HBV assay receives marketing approval from FDA

Abbott announced today it has received approval from the U.S. Food and Drug Administration to market the Abbott RealTime HBV assay for measuring viral load or the amount of hepatitis B virus in a patient's blood. It is the first and only approved test capable of automating HBV viral load testing from sample extraction to final results.

2 Sep 2010

Laboratoires Thea acquires Mydriasert ophthalmic insert for cataract surgery

Laboratoires Thea, the leading independent ophthalmic group in Europe, completes its innovative product range with the announcement of the final acquisition of Mydriasert(R). Mydriasert(R), the 1st mydriatic ophthalmic insert, is indicated for dilated fundus examination (DFE) or cataract surgery, the most widely implemented surgical procedure. Regarding cataract surgery, the market represents close to 300 000 procedures in the UK and Ireland and 3 million in Europe each year.

2 Sep 2010

Scientist develops new ETS procedure to treat hyperhidrosis

Millions of people in the United States suffer from a medical condition that can unpredictably cause them to begin sweating as if they had just finished running a marathon.Hyperhidrosis, or excessive sweating, is a common disorder that first becomes noticeable during childhood or adolescence. People with hyperhidrosis could be doing something as leisurely as lying down or watching television and sweat will still soak their bodies.

2 Sep 2010

ESC updates Clinical Practice Guidelines on devices for heart failure treatment

The European Society of Cardiology (ESC) today announces a focused update of its Clinical Practice Guidelines covering Device Therapy in Heart Failure. This is the first time that current ESC guidelines have been updated, reflecting the pace of research in this field and the importance of recently published evidence.

2 Sep 2010

UTHealth professor to receive NIH Director's Pioneer Award

Valentin Dragoi, Ph.D., an associate professor of neurobiology and anatomy at The University of Texas Health Science Center at Houston (UTHealth), is one of 17 researchers to win a 2010 National Institutes of Health Director's Pioneer Award. The award supports scientists who propose revolutionary, high-impact approaches to major challenges in biomedical and behavioral research.

2 Sep 2010

Quidel's RapidVue hCG lateral flow pregnancy immunoassay granted FDA 510(k) clearance

Quidel Corporation, a leading provider of rapid diagnostic testing solutions, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of Quidel's RapidVue® hCG test, a lateral flow pregnancy immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG).

2 Sep 2010

CDC launches new online video to provide information on Assisted Reproductive Technology

Reproductive health experts at the Centers for Disease Control and Prevention (CDC) have launched three new online videos to provide science-based information for anyone considering Assisted Reproductive Technology (ART).

2 Sep 2010

Prometheus launches Crohn's Prognostic test

Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, today announced the commercial launch of its proprietary PROMETHEUS® Crohn's Prognostic test. This novel and unique diagnostic represents a significant advance in the Prometheus Inflammatory Bowel Disease (IBD) franchise of diagnostic and prognostic tests, and complements the market-leading PROMETHEUS® IBD Serology 7.

2 Sep 2010

Hospitals ill-prepared for move to electronic medical records, survey finds

Government requirements for hospitals to get cash rewards for the "meaningful use" of electronic medical records may be too stringent for many facilities, which lack the tech savvy to meet them, according to Mass Device, a New England-based medical device business newsletter. "A small fraction of U.S. hospitals reported using electronic medical records software last year and even fewer would have met new requirements for 'meaningful use' of the systems in 2009, according to an American Hospital Assn. survey."

2 Sep 2010

Ovatech completes Phase 2 study of Ovaprene non-hormonal, intravaginal contraceptive ring

Ovatech, an emerging women's health-focused company, announced today that the Company's Phase 2 clinical study of its non-hormonal, intravaginal contraceptive ring, Ovaprene, has been successfully completed. Ovaprene is a 'one-size-fits-all' patented, female-controlled, intravaginal organic silicone ring barrier-contraceptive that is designed to continuously release spermiostatic and spermicidal non-drug agents over a four-week period.

2 Sep 2010

Study to determine how often chronic Lyme disease is diagnosed and treated

A study soon to be published in The Journal of Pediatrics attempts to determine how often chronic Lyme disease is actually being diagnosed and treated.

2 Sep 2010

Amedica Corporation receives patent for knee implant prosthesis with monoblock ceramic tibial component

Amedica Corporation, a spinal and orthopaedic implant and instrument company focused on unique silicon nitride (SiN) ceramic technologies, announced today that it has been granted United States Patent No. 7,776,085 B2, covering an improved knee implant prosthesis that features a monoblock ceramic tibial component for articulation with natural or prosthetic (resurfaced) femoral surfaces.

2 Sep 2010

Tech News: Feds name health IT certifiers; IBM seeks to crack China's health sector

Federal health officials gave two firms -- the Certification Commission for Health Information Technology in Chicago, Ill., and the Drummond Group in Austin, Texas, -- the power to certify electronic medical record vendors effective immediately, The Hill reports. "As providers move toward mandatory adoption of EHR systems, HHS created an incentive program designed to encourage the transition." Hospitals and doctors can receive payments for achieving "meaningful use," a set of requirements laid out by federal officials.

2 Sep 2010

Device / Technology News

LifeCell, Novadaq Technologies sign exclusive sales, marketing agreement

InfraReDx receives 510(k) clearance to market LipiScan IVUS Coronary Imaging System

GI Dynamics, Elemental Healthcare sign agreement for distribution of EndoBarrier Gastrointestinal Liner

MIRACLE project to develop lab-on-chip system for diagnosing cancer

Central Logic Core Web-based software application for bed management launched

Leon-Berard Cancer Center to install CyberKnife VSI System

First genetically engineered rat derived from rat ES cells developed with StemCells' technology

Abbott RealTime HBV assay receives marketing approval from FDA

Laboratoires Thea acquires Mydriasert ophthalmic insert for cataract surgery

Scientist develops new ETS procedure to treat hyperhidrosis

ESC updates Clinical Practice Guidelines on devices for heart failure treatment

UTHealth professor to receive NIH Director's Pioneer Award

Quidel's RapidVue hCG lateral flow pregnancy immunoassay granted FDA 510(k) clearance

CDC launches new online video to provide information on Assisted Reproductive Technology

Prometheus launches Crohn's Prognostic test

Hospitals ill-prepared for move to electronic medical records, survey finds

Ovatech completes Phase 2 study of Ovaprene non-hormonal, intravaginal contraceptive ring

Study to determine how often chronic Lyme disease is diagnosed and treated

Amedica Corporation receives patent for knee implant prosthesis with monoblock ceramic tibial component

Tech News: Feds name health IT certifiers; IBM seeks to crack China's health sector

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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