Medical Devices News and Research

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ReVision Optics completes enrollment, initial follow up in PresbyLens Phase I clinical trial for presbyopia

ReVision Optics, a leading company in the research, development and manufacture of implantable medical devices designed to assist patients that need reading glasses, announced today that it has completed enrollment and initial follow up in Phase I of its US clinical trial and has filed for expansion. The clinical trial is for the study of the PresbyLens, recently renamed Vue+, for the improvement of near vision in patients with presbyopia, the age-related loss of near vision.

9 Sep 2010

Spirus Medical obtains Japanese marketing approval for ENDO-EASE line of endoscopy devices

Spirus Medical announced today that it has obtained marketing approval from the Japanese Ministry of Health, Labor and Welfare for the company's proprietary ENDO-EASE line of endoscopy devices. The Endo-Ease Endoluminal Advancement System features novel "over-tubes" that use a spiral design utilizing simple rotation to facilitate enteroscopy, colonoscopy and ileoscopy.

9 Sep 2010

Arcapita enters equity investment, option to purchase agreement with St. Jude Medical

Arcapita, a global investment company, announced today that Atlanta-based CardioMEMS, an Arcapita Ventures portfolio company, has entered into an equity investment and option to purchase agreement with St. Jude Medical, a global medical device company.

9 Sep 2010

PositiveID to sell Health Link personal health record business to Health Plexus

PositiveID Corporation announced today that it has agreed to sell its Health Link personal health record business for $1 million to Health Plexus, LLC. The Company will also retain the right to royalties on future Health Link revenues. Health Link is the Company's web-based personal health record (PHR), which is non-core to the Company's primary HealthID division. HealthID develops and markets unique medical devices, with a focus on diabetes management, and rapid medical testing products.

8 Sep 2010

Vela Laboratories renews GMP certificate for analytical and Quality Control laboratories

Vela Laboratories, a provider of analytical services to the global biopharmaceutical industry, today announced the renewal of the GMP certificate for its analytical and Quality Control laboratories until 2013.

8 Sep 2010

FDA clears Viking Systems' Next Generation 3DHD visualization system

Viking Systems, Inc. announced today that it has received clearance of its 510(k) application by the Food and Drug Administration related to its Next Generation 3DHD visualization system. The System is scheduled for market launch in Washington D.C. at this year's American College of Surgeons' Annual Clinical Congress which will be held from October 3-7.

8 Sep 2010

Health law rollout effects: Delivering 'accountable' care, device tax, nursing mothers

Today's updates on the continuing implementation of the health law include Medicare chief Don Berwick's behind the scenes push for 'accountable care organizations,' tax anxiety in the medical device industry, and the promise of new help for pregnant women.

8 Sep 2010

VirtualScopics enters molecular imaging collaboration with ABX-CRO

VirtualScopics, Inc., a leading provider of quantitative imaging for clinical trials, today announced it has entered into a scientific collaboration, specific to molecular imaging, with ABX-CRO, a Dresden, Germany based full-service contract research organization. The collaboration joins two of the scientific pioneers in the use of advanced imaging for the clinical study of drugs and medical devices.

7 Sep 2010

St. Jude Medical to invest $60M in CardioMEMS

St. Jude Medical, Inc., a global medical device company, and privately-held CardioMEMS today announced that they have reached an agreement under which St. Jude Medical will make a $60 million equity investment in CardioMEMS, a medical device company that has developed a wireless sensing and communication technology to assess cardiac performance.

7 Sep 2010

TSO3 engaged in regulatory discussions for refiling of new generation sterilizer's 510(k) clearance

TSO3 Inc., an innovator in sterilization technology for medical devices in healthcare settings, today announced that the Company is having productive discussions with US regulators, including a very recent face-to-face meeting. The Company is actively engaged in the changing US regulatory process intended to lead to the refilling for 510(k) clearance on its new generation sterilizer.

7 Sep 2010

RevMed secures contract with Medical Investment to produce fixed needle safety syringe

RevMed has secured a binding 5 Year contract to produce 5M syringes/month of its 3mL fixed needle safety syringe with Medical Investment Group, LLC (MIG). MIG, a Massachusetts Limited Liability Company, will fulfill this obligation through its relationship with an internationally certified global medical device manufacturer.

7 Sep 2010

Myths, controversy surround health reform law

News outlets are following the politics and rhetoric surrounding the new health law.

4 Sep 2010

Forbion Capital Partners announces final closing of FCF I, FCF II fund

Forbion Capital Partners, a leading investment firm dedicated to the life science sector, today announces the final closings of both FCF I Co-Invest Fund and of FCF II, raising a total of more than €190m ($240m). Forbion's €54m Co-Invest Fund aims to invest alongside FCF I in a select number of late-stage FCF I portfolio companies.

3 Sep 2010

Accentus Medical signs licence agreement for Agluna anti-infective technology with Zimmer

Accentus Medical, a leading UK medical technology company that supplies advanced coatings and surface treatments to the medical device industry, announced today that it has signed a Licence and Services Agreement with Zimmer Holdings, Inc., a global market leader in musculoskeletal care. This agreement will enable the use of Accentus Medical's Agluna® anti-infective technology on a potentially broad range of Zimmer products.

3 Sep 2010

NEJM publishes study on Xpert MTB/RIF test for rapid molecular detection of TB and rifampin resistance

Cepheid today announced that its Xpert® MTB/RIF test was the subject of a study published in the latest edition of the New England Journal of Medicine (NEJM), "Rapid Molecular Detection of Tuberculosis and Rifampin Resistance." The complete study is now available online (http://www.nejm.org) and will appear in the September 9 print edition.

3 Sep 2010

Shanghai SynTheAll Pharmaceuticals receives ISO 14001 certification

WuXi PharmaTech, a leading pharmaceutical, biotechnology and medical device research and development outsourcing company with operations in China and the United States, announced today that its manufacturing subsidiary, Shanghai SynTheAll Pharmaceuticals Co. Ltd. (STA) passed the ISO 14001: 2004 inspection conducted by SGS Group on July 1 and received formal ISO 14001 certification on July 30.

3 Sep 2010

Saint Barnabas Medical Center installs ZOLL's AutoPulse Non-Invasive Cardiac Support Pump

ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, announced today that Saint Barnabas Medical Center, one of the largest non-profit, non-sectarian hospitals in New Jersey, has installed the AutoPulse® Non-Invasive Cardiac Support Pump for resuscitative capabilities in the hospital's emergency department.

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

Unitract Tuberculin syringe clears FDA 510k market clearance

Unilife Corporation, today announced that its Unitract Tuberculin (TB) Syringe has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA).

2 Sep 2010

Medical Devices News and Research

ReVision Optics completes enrollment, initial follow up in PresbyLens Phase I clinical trial for presbyopia

Spirus Medical obtains Japanese marketing approval for ENDO-EASE line of endoscopy devices

Arcapita enters equity investment, option to purchase agreement with St. Jude Medical

PositiveID to sell Health Link personal health record business to Health Plexus

Vela Laboratories renews GMP certificate for analytical and Quality Control laboratories

FDA clears Viking Systems' Next Generation 3DHD visualization system

Health law rollout effects: Delivering 'accountable' care, device tax, nursing mothers

VirtualScopics enters molecular imaging collaboration with ABX-CRO

St. Jude Medical to invest $60M in CardioMEMS

TSO3 engaged in regulatory discussions for refiling of new generation sterilizer's 510(k) clearance

RevMed secures contract with Medical Investment to produce fixed needle safety syringe

Myths, controversy surround health reform law

Forbion Capital Partners announces final closing of FCF I, FCF II fund

Accentus Medical signs licence agreement for Agluna anti-infective technology with Zimmer

NEJM publishes study on Xpert MTB/RIF test for rapid molecular detection of TB and rifampin resistance

Shanghai SynTheAll Pharmaceuticals receives ISO 14001 certification

Saint Barnabas Medical Center installs ZOLL's AutoPulse Non-Invasive Cardiac Support Pump

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

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

Unitract Tuberculin syringe clears FDA 510k market clearance

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