Home › Resources › Medical Device Industry News

Medical Device Industry News

  • Tryton Medical Aims for FDA Approval for Side Branch Stent

    At EuroPCR, Tryton Medical (Newton, MA) announced its new initiative to win favor with FDA regulators. As of now. the Tryton Side Branch Stent has approval in the Middle East, Russia and Europe. However, FDA approval has eluded the implant so far. Under the leadership of the Nordic-Baltic Bifurcation Study Group, a new 150-patient trial may help get the stent gain entry into the U.S. market.

  • Drug-Coated Balloon Shows Promise in Covidien's First-in-Human Clinical Study

    Covidien (Mansfield, MA) recently released positive results for its new first-in-human drug-coated balloon as the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Congress in Paris wraps up.

  • Intuitive Surgical Wins First da Vinci Patient Injury Lawsuit, 25 Plus Cases Pending

    While Intuitive Surgical (Sunnyvale, CA) faces dozens of patient injury lawsuits related to its da Vinci robotic surgery system, its first patient patient injury lawsuit has ended in victory for the company, according to Bloomberg. In the 10–2 verdict, a Washington jury decided that the company did not demonstrate negligence in its robotic surgery training program.

  • Toshiba and Others Battle for Stake in Panasonic’s Healthcare Division

    With Panasonic selling a stake in its healthcare division, several major industry players are vying for a piece of the ailing electronics manufacturer. While early rumors indicated that Panasonic would sell its entire healthcare division, the company will retain partial ownership of its medical device group. The overall group could be worth as much as $1 billion.

  • BPA Levels in Medical-Grade Polycarbonate Not Risky, Ethicon Study Shows

    Bisphenol A (BPA) has has been linked by health experts to of health problems including cancer and reproductive toxicity. In fact, last month, the state of California added the compound to a list of chemicals known to cause reproductive problems under Proposition 65. In 2009, the compound came under the scrutiny of FDA.

  • Medtronic Receives First CE Mark for Valve-in-Valve Procedures

    Medtronic has announced that the CE Mark would cover valve-in-valve procedures that use the company’s CoreValve Evolut and CoreValve transcatheter aortic valve implantation systems in patients suffering from degenerated bioprosthesis surgical aortic valves. This represents the first CE Mark approval for valve-in-valve procedures.

  • Stentys Cardiac Stent Reduces Heart Attack Rate One Year After Implantation

    Stentys (Paris, France) has announced positive results from its Apposition III trial. The primary endpoint of the study was the incidence of major adverse cardiac events (MACE) at 12 months. For the patient population in the study, the MACE percentage was 9.3%. The MACE rate for conventional stents averages 11.1%.

  • 3-D Printer Used to Create Artificial Airway for Child

    Kaiba Gionfriddo was born with a condition known as tracheobronchomalacia. In this condition, an individual’s airway walls are so weak that they can collapse. Gionfriddo first experienced breathing issues at six weeks old. While at a restaurant with his parents, the young boy stopped breathing. While the boy was resuscitated, Gionfriddo continued to experience breathing problems.

  • Intuitive Surgical Faces Millions in Damages in Jury Trial, Issues Product Warning

    Surgical robotics pioneer Intuitive Surgical is facing at least 26 lawsuits that allege its flagship da Vinci system played a role in injuring patients. In the first case alone, the company could lose as much as $8.45 million in a Seattle-based case filed by attorneys for the estate of Fred Taylor, a cancer patient who had his prostate gland removed in a robot-assisted procedure in 2008.

  • Study: Covidien's RF Ablation Device Effective against Barrett's Esophagus

    Covidien announced that its ablation therapy device can reduce the progression of Barrett's esophagus, a precancerous condition, to full-blown esophageal cancer. The company disclosed the news during Digestive Disease Week 2013, an event held in Orlando, FL.

Latest News

More News

Latest Resources

More Resources