Medical Device Industry News

  • Stryker Announces New Global Initiative

    Stryker, a medical device manufacturer based in Kalamazoo, Michigan, announced that it will place a higher emphasis on markets outside the United States. At the JP Morgan Healthcare Conference, Stryker CEO and president Kevin Logo detailed the new plans for the company.

  • Medtronic Sued for Alleged Deceptive Business Practices

    Medtronic, a medical device manufacturer based in Minneapolis, Minnesota, was named as the defendant in a federal lawsuit over its allegedly deceptive business practices. According to the three plaintiffs named in the federal lawsuit, Medtronic used deceptive business practices to market defective and dangerous products. This lawsuit follows accusations of illegal marketing practices like doctor kickbacks for its defibrillator products. Medtronic has already settled that case.

  • MobileCare Monitor by AFrame Receives FDA Clearance

    AFrame Digital, a medical device manufacturer based in Reston, Virginia, received clearance from the United States Food and Drug Administration (FDA) for its MobileCare monitoring system. The Class II approval of the device follows Class I approval by the FDA in 2009. According to a press release by the company, the MobileCare health monitor uses a specialized wireless wristwatch device to monitor patient gait. The device can transmit real-time data to caregivers or other healthcare providers through a smartphone, tablet or other mobile devices.

  • New House Bill Would Create FDA Mobile Health Division

    A new bill was introduced on the House floor by representative Mike Honda (D-CA). The new bill, dubbed the Healthcare Innovation & Marketplace Technologies Act, calls for the creation of a new FDA division to boost health information technologies and wireless health programs in the United States.

  • Boston Sci's New Stent Technology Enters Clinical Trial

    Boston Scientific, a global medical device manufacturer based in Natick, Massachusetts, announced that it has successfully enrolled a patient in an Evolve II trial of the company’s Synergy stent. The Synergy drug-eluting stent is used for the delivery of targeted medications. With data from the clinical trial, the company hopes to provide further backing for its approval applications in Japan and the United States.

  • Sorin Purchases Minority Share in Highlife SAS

    The Sorin Group, an Italian medical device manufacturer, announced that it had invested $5.4 million in Highlife SAS. Highlife SAS is an early-stage company working on the development of transcatheter mitral valve replacement technologies. The minority investment by the Sorin Group includes an option to buy the cardiovascular technology company. Georg Bortlein is one of the prominent founders of Highlife SAS. His history includes co-founding CoreValve, a company that specialized in aortic valve implantation technology. CoreValve was later purchased by Medtronic.

  • Boston Scientific Loses Patent War with Cardium Therapeutics

    Boston Scientific, a global medical device manufacturer based in Natick, Massachusetts, recently lost a patent war against Cardium Therapeutics, a healthcare company based in San Diego, California. The disputed patent is based on Cardium Therapeutics’ gene therapy technology that is used in the treatment of coronary heart disease.

  • EU Grants CE Mark Approval for Imagine Eyes Retinal Camera

    Imagine Eyes, a medical device manufacturer based in Orsay, France, received CE Mark approval in the European Union for its new retinal imaging system. According to information released by the company, the product is the first clinically-approved adaptive optics platform system.

  • FDA Grants PMA for Cook Medical's Zilver PTX Stent

    Cook Medical, a healthcare device manufacturer based in Bloomington, Indiana, recently received premarket approval (PMA) from the United States Food and Drug Administration (FDA) for its Zilver PTX stent. The Zilver PTX stent is the first drug-eluting stent for peripheral artery disease that has received approval in the U.S.

  • Qualcomm Life to Make 2net Hub and Platform Available in Europe

    Qualcomm Life, a subsidiary of global semiconductor company Qualcomm Technologies, announced that its wireless healthcare services will be available in Europe. The subsidiary’s flagship product, the 2net Platform and Hub, will allow healthcare providers and medical device manufacturers to link their systems through a cloud-based solution. This will help healthcare providers monitor patient biometrics and other information quickly and easily.