Medical Devices News and Research

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United American Healthcare acquires Pulse Systems

United American Healthcare Corporation today announced it has acquired privately held Pulse Systems, LLC. Based in Concord, Calif., Pulse Systems, LLC provides contract manufacturing services to the medical device industry, with a focus on precision laser-cutting capabilities and the processing of thin-wall tubular metal components, sub-assemblies and implants, primarily in the cardiovascular market. For the fiscal year ended Dec. 31, 2009, Pulse Systems generated revenue of approximately $9.2 million.

19 Jun 2010

St. Jude Medical's Therapy Cool Flex Ablation Catheter granted European CE Mark approval

St. Jude Medical, Inc., a global medical device company, today announced European CE Mark approval of the Therapy™ Cool Flex™ Ablation Catheter at the 17th World Congress in Cardiac Electrophysiology and Cardiac Techniques (CardioStim). The ablation catheter is the industry's first to have a fully-irrigated and flexible tip, which can potentially improve the safety and efficacy of cardiac ablation procedures.

18 Jun 2010

Drug makers face tightened regulations by FDA and less clout at medical meetings

The Washington Post: "The Food and Drug Administration this week began posting online the results of safety evaluations of recently approved drugs and vaccines. The action follows a law enacted in 2007 that requires the agency to provide more safety information to consumers and health professionals. The evaluations must be conducted 18 months after a new drug comes on the market.

18 Jun 2010

St. Jude Medical commences enrollment in LAPTOP-HF study

St. Jude Medical, Inc., a global medical device company, today announced the first enrollment in its LAPTOP-HF (Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy) study. The goal of the LAPTOP-HF study is to demonstrate that the new investigational left atrial pressure (LAP) management system safely and effectively improves outcomes in patients with heart failure (HF).

17 Jun 2010

Kaplan EduNeering, DIA announce strategic alliance to create online educational offerings

Kaplan EduNeering, a leading provider of compliance and knowledge management solutions, and the Drug Information Association (DIA), a global professional member association, announced a new strategic alliance to create online educational offerings for biotechnology, pharmaceutical, academic, and regulatory professionals around the world.

17 Jun 2010

China Yongxin Pharmaceuticals expands chain of drugstores to 103

China Yongxin Pharmaceuticals Inc., one of the leading health products distribution and retail sales companies in China, today announced the opening of three new chain drugstores in Changchun City. These new openings bring the Company's total number of stores to 24 in Changchun City, and 103 throughout Northeastern China, exceeding the Company's previously projected rate of growth in terms of number of locations.

17 Jun 2010

St. Jude Medical's EnSite Contact Technology platform receives European CE Mark approval

St. Jude Medical, Inc., a global medical device company, today announced European CE Mark approval of the EnSite Contact™ Technology platform at the 17th World Congress in Cardiac Electrophysiology and Cardiac Techniques (CardioStim).

17 Jun 2010

FDA seeks public input on regulation of laboratory-developed tests

The U.S. Food and Drug Administration today announced plans to hold a public meeting on July 19-20, 2010, to discuss how the agency will oversee laboratory-developed tests (LDTs).

17 Jun 2010

New legislation will impede use of MRI in medical research

Europe must act to prevent new legislation impeding the use of magnetic resonance imaging (MRI) in medical research, diagnosis and treatment, states the European Science Foundation (ESF) in a new report. The report is endorsed by the European Medical Research Councils, representing the medical research communities in 30 countries.

17 Jun 2010

TechniScan launches clinical study of Warm Bath Ultrasound system in Rochester

TechniScan, a medical device company engaged in the development and commercialization of an automated 3D breast ultrasound imaging system, today announced that it has launched a clinical study in Rochester, Minn., its third new clinical site to commence in the last five months.

17 Jun 2010

InfraReDx to demonstrate LipiScan coronary imaging system during CCC Symposium

InfraReDx, Inc., an innovative medical device company focused on developing novel diagnostic imaging technologies to accurately identify and characterize diseased tissues, today announced that its LipiScan Coronary Imaging System will be featured at the 13th Annual Live Symposium of Complex Coronary & Vascular Cases being held at The Mount Sinai Medical Center of New York, from June 16-19, 2010.

16 Jun 2010

Covidien, Somanetics sign definitive merger agreement

Covidien plc and Somanetics Corporation today announced that they have signed a definitive merger agreement under which Covidien will acquire all of the outstanding shares of Somanetics Corporation for $25.00 per share in cash, for a total of $250 million, net of cash acquired.

16 Jun 2010

Senior U.S. healthcare executives divided over healthcare reform: Survey

With their world turned upside down by enactment of healthcare reform, senior U.S. healthcare executives are divided over whether the new environment offers growth possibilities or challenges to the survival of existing business models, a new survey shows.

16 Jun 2010

joimax moves into larger premises in Germany, US

The medical devices company joimax(R) GmbH is moving into new premises both in Germany and the US. "Growth requires space" had already been the motto of the last company move back in 2005.

16 Jun 2010

TYRX successfully implants AIGISRx device in 10,000 patients in the U.S.

TYRX, Inc. announced today that it has successfully implanted its AIGISRx device in 10,000 patients in the United States. The AIGISRx device is an antibacterial mesh technology that securely holds a pacemaker or implantable cardioverter defibrillator in place to create a stable environment, while delivering antimicrobial agents, rifampin and minocycline. These antimicrobial agents have been shown to reduce infections associated with medical devices in multiple randomized controlled trials.

15 Jun 2010

U.S. video, high-tech and integrated OR equipment market to exceed $2 billion by 2016

According to a new report by iData Research, the leading global authority in medical device and pharmaceutical market research, the overall U.S. video, high-tech and integrated operating room (OR) equipment market was worth $1.49 billion in 2009. This market, which experienced a strong decline during the economic recession, is expected to recover, exceeding $2 billion by 2016.

15 Jun 2010

Cardio-perfusion circuit patent portfolio offered for sale

ICAP Ocean Tomo, the intellectual property brokerage division of ICAP plc (IAP.L), is offering for sale a portfolio of three US issued patents relating to a condensed perfusion circuit for cardiac bypass. The technology of the portfolio should be of interest to any medical device company currently working in the cardiac surgery sector, or looking to establish a leading position in this growing field. This portfolio is a strong addition to ICAP Ocean Tomo's growing Bio/Life Sciences practice.

15 Jun 2010

Medicare coverage of unproven mammography screening device leads to surge in usage

In a study illustrating the potentially powerful influence of political pressure on medical practice, a UC Davis physician-researcher has found that use of a largely unproven mammography screening device has surged since Medicare began covering its cost.

15 Jun 2010

Synergetics third-quarter 2010 sales increase 5.3% to $13.9 million

Synergetics USA, Inc., a medical device company that designs, manufactures, and markets innovative microsurgical instruments for ophthalmic and neurosurgical applications, today announced its results for the third quarter and nine months ended April 30, 2010.

15 Jun 2010

Ingen Technologies' new SMART Nasal Cannula unveiled at Alpha-1 19th National Education Conference

Ingen Technologies, Inc., a medical device manufacturer with an emerging new medical product line for the respiratory market worth an estimated $4 billion in the U.S. and $8 billion globally, unveiled their new SMART Nasal Cannula in Orlando-Florida last week at the Alpha-1 19th Annual National Education Conference.

14 Jun 2010