Endovastec Hyperflex Balloon Catheter Wins Commercial Win in Japan

  • Key Tech names next CEO as co-founder plans to retire

    Key Tech co-founder Jenny Regan plans to retire as CEO of the product development company at the end of August, making way for vice president of strategy Alex Flamm. to take his place. Regan has been CEO since she and her co-founders started the Baltimore company in 1998. The company said it now has 75… […]

  • How to Join the MDO Contributor Network

    Some of the most valuable insights into medical design and outsourcing can be found in expert-written MDO Contributor Network articles covering medical technology innovation, design and manufacturing – and it’s all thanks to readers like you. If you want to share the latest research, developments, or lessons learned from your organization to inspire and empower others… […]

  • Pulsed-field ablation enables new precision cancer treatments

    Macro-scale electroporation energy manipulates cellular behavior for efficient drug delivery. Saeid Movahed and Daniel Friedrichs, Minnetronix Medical When applied to tissue, electric fields can enable precise and selective ablation effects by manipulating electrical properties at the cellular scale. One effect, called electroporation or electropermeabilization, has many therapeutic and diagnostic applications, including tumor ablation and intercellular DNA delivery,… […]

  • What You Need to Know About the FDA’s Total Product Lifecycle Advisory Program Pilot

    An FDA initiative to improve medical device development is closer than ever to becoming a reality after surviving negotiations with industry over the reauthorization of Medical Device User Fee (MDUFA) changes. My last article on MDUFA V discussed the FDA’s Total Product Lifecycle Advisory Program (TAP) pilot featured in the… […]

  • This catheter with variable stiffness could simplify cardiac procedures

    Swiss researchers have developed a variable-stiffness catheter that can switch from a soft to a stiff state. A team of researchers from the Technical University EPFL and ETH Zurich developed the catheter to make minimally invasive surgical procedures such as the treatment of cardiac arrhythmia simpler and more effective. Catheters are inserted into arteries and directed to treatment areas… […]

  • Medtronic completes first patient implants in tibial neuromodulation trial for bladder control

    Medtronic (NYSE: MDT) announced that it has completed the first patient implants in the pivotal Titan 2 study of its investigational neuromodulation device. Medtronic’s Titan 2 trial, based in Fridley, Minn., will assess the safety and effectiveness of the company’s implantable tibial neuromodulation (TNM) device in people with overactive bladder (OAB). Discover the whole story on our partner site, MassDevice. […]

  • Sterifre Medical prepares to launch its Aura desktop disinfection device

    Sterifre Medical demonstrates its Aura device and woos investors as it prepares to launch the automatic point-of-care disinfection system. The Aura is a portable machine that circulates hydrogen peroxide and activated oxygen at the touch of a button to disinfect stethoscopes, sensors, pumps, tablets, phones, keys, badges and all that you can install… […]

  • FDA releases details of MDUFA V after negotiations with industry

    The FDA today released details of its agreement with the medical technology industry for the reauthorization of Medical Device User Fee (MDUFA) changes. If passed by Congress and signed into law, it would be the fifth version of the User Fees and Medical Devices Modernization Act of 2002. AdvaMed hailed the framework earlier this month after… […]

  • FDA Clears Quantum Surgical’s Robot-Assisted Tumor Ablation Technology

    Quantum Surgical today announced that it has received 510(k) clearance from the FDA for its Epione interventional oncology robotic platform. Quantum Surgical, based in Montpellier, France, has designed Epione, a robot-assisted system, to plan, target, deliver and confirm tumor ablation in the minimally invasive treatment of liver cancer. Discover the whole story on our partner site, MassDevice. Post FDA clears robotic assist from Quantum Surgical […]

  • Has CE marking lost its appeal for developers of new medical devices?

    Medical technology companies are increasingly turning to the FDA instead of the European CE mark when launching new products, according to a new report. “Historically, CE marking has been the preferred route for registering new medical technologies because its processes were faster, cheaper and more predictable. The situation is now reversed,” write the authors of… […]

  • This tentacle-shaped magnetic robot could navigate the lungs

    Engineers at the University of Leeds have developed a tentacled magnetic robot to pass through the narrow tubes of the lungs. University scientists and engineers have done a proof-of-concept for a robotic device that can reach the smallest bronchial tubes to take tissue samples and deliver cancer treatment. The tentacle robot has… […]