Medical Device Industry News

  • FDA Exempts Over 1000 Devices from 510(k) Requirement

    The 21st Century Cures Act paved the way for deregulation of a host of medical devices ranging from surgical lights to dentures.Kristopher Sturgis

  • VA and Mobius Arm First Veterans with a Motorized Prostheses

    After years in the making, the LUKE arm is the first fully integrated prosthetic arm for amputees across a range of levels of amputation. Nancy Crotti Two military veterans who participated in clinical trials that supported FDA clearance of the LUKE arm have received the motorized prosthetic device.

  • Is This Test a Major Advancement for Blood Diseases?

    FDA has granted its first-ever authorization for a test that uses flow cytometry to aid in the detection of several leukemias and lymphomas. Staff Report  

  • Could This Bring Epilepsy Surgery into the 21st Century?

    Researchers from Cleveland Clinic, Mayo Clinic, and the University of Campinas in Brazil, will use a $3.4 million NIH grant to develop a comprehensive risk calculator to determine which patients will most benefit from epilepsy surgery. Amanda Pedersen

  • Is Medtronic Gearing Up to Buy Glooko?

    The diabetes data management company aims to expand its sales, marketing, and development teams through new investors to deepen its expertise in data analytics. Kristopher Sturgis

  • Researchers Take a Softer Approach to Wearable Robots

    Clothing-like exosuits represent a new class of wearable robots for people with mobility challenges, including stroke survivors. Kristopher Sturgis

  • This Gadget Can Monitor Your Heart Better, From Home

    Developer seeks to combine device with machine-learning algorithms to automatically alert patients and physicians of worsening heart failure.Nancy CrottiThe company that introduced one of the first smart stethoscopes just landed FDA clearance for a combined digital stethoscope and electrocardiogram that patients can use at home.

  • Challenge Accepted: French Company Takes On Radiosensitivity

    Neolys Diagnostics says its kit and lab-based test can detect sensitivity to radiation therapy for cancer patients.Nancy Crotti

  • Edwards' Competitive Edge in TAVR Gets Even Sharper

    Editor's Note: This story has been updated to clarify that Medtronic was first to recieve FDA approval for aortic valve-in-valve replacement procedures in 2015, while Edwards is now first to recieve the valve-in-valve indication for mitral valve replacement procedures. 

  • J&J to Swallow Up GERD-Prevention Device Maker

    Torax Medical makes a magnetic device that keeps stomach acid in place.Nancy CrottiA subsidiary of Johnson & Johnson is buying a small company that makes a surgical solution to gastrointestinal reflux disease (GERD).