Latest Headlines

  1. FDA Issues Final Guidance For Medical Device Accessories
    1/6/2017

    While remaining consistent with the 2015 draft guidance in many respects, the finalized guidance clarifies the scope of the policy following the passage of the 21st Century Cures Act and describes in greater detail how manufacturers may obtain classification of a new accessory type via the de novo process.

  2. Global Endoscopy Devices Market To Reach $40M By 2022
    1/6/2017

    Endoscopy Devices Market Report, published by Allied Market Research, forecasts that the global market is expected to garner $40,854M by 2022 from $27,273 in 2015, registering a CAGR of 5.7% during the period 2016 to 2022.

  3. House Bill To Permanently Repeal Device Tax Filed Anew
    1/5/2017

    U.S. Reps. Erik Paulsen (R-Minn.) and Ron Kind (D-Wisc.) have reintroduced a bill in the U.S. House of Representatives seeking to permanently repeal the medical device excise tax, which currently is suspended until Dec. 31, 2017.

  4. First Real-Life Study Tests Feasibility Of Solar-Powered Implants
    1/5/2017

    Researchers in Switzerland have produced real-life evidence that implanted devices could one day be powered by solar energy. Study participants who wore solar power measurement devices throughout their regular daily activities generated the energy required to power the average contemporary pacemaker, regardless of the weather, season, or age.

  5. Globus Medical’s Robotic Surgery Guidance System Earns CE Mark
    1/5/2017

    Globus Medical, Inc. (NYSE: GMED), a leading musculoskeletal implant manufacturer, today announced that the Excelsius GPS™, a revolutionary system providing robotic trajectory guidance and navigation, is now CE marked.

  6. ivWatch, A Continuous IV Monitor, Cleared By FDA For Pediatric Patients
    1/5/2017

    Medical device manufacturer ivWatch, LLC today announced United States availability of the ivWatch Model 400 for pediatric patients under the age of 18.

  7. Nikon, Verily Partnership Combines Machine-Learning With Advanced Retinal Imaging
    1/4/2017

    Nikon and Verily have signed a strategic partnership to co-develop advanced screening technology for eye diseases associated with diabetes. By pairing machine-learning capabilities with next-generation retinal imaging, the companies hope to offer earlier diagnosis of diabetic retinopathy and diabetic macular edema — two leading causes of blindness worldwide.

  8. FDA Finalizes Guidance On Benefit-Risk Factors Influencing Device Availability, Compliance, Enforcement Decisions
    1/4/2017

    The U.S. Food and Drug Administration (FDA) has finalized its guidance on benefit-risk factors to consider when making medical device product availability, compliance, and enforcement decisions across the total product life cycle. The document provides a general framework for FDA and stakeholders that sets forth overarching benefit-risk principles.

  9. Breathalyzer Diagnoses 17 Different Diseases Using A Single Breath
    1/3/2017

    A team of Israeli scientists has further developed its breathalyzer technology, and a recent clinical study demonstrated an 86 percent success rate identifying 17 different diseases. The researchers’ nanoarray uses data collected from over 1,400 subjects to establish “breathprints” for diseases like cancer and multiple sclerosis, and then relies upon artificial intelligence (AI) technology to make a diagnosis.

  10. FDA Finalizes Cybersecurity Guidance On Postmarket Devices
    1/3/2017

    The U.S. Food and Drug Administration (FDA) has released a final guidance covering management of postmarket cybersecurity vulnerabilities for marketed and distributed medical devices.