1. Articles from mddionline.com

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    1. Cervical vertebral body replacement system made from PEEK-Optima HA receives FDA 510(k) clearance | MDDI Online

      Cervical vertebral body replacement system made from PEEK-Optima HA receives FDA 510(k) clearance | MDDI Online

      Omnia Medical (Morgantown, WV) has been granted the first FDA 510(k) clearance for a cervical vertebral body replacement (VBR) system manufactured from PEEK-Optima HA Enhanced polymer from Invibio Biomaterial Solutions (Thornton Cleveleys, UK). The so-called Boxcar system is designed for use in cervical-corpectomy procedures, the replacement of a collapsed, damaged or unstable vertebral body located in the cervical spine.

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      Mentions: Spine
    2. Devices Continue to Gain Traction As Opioid Epidemic Rages On

      Devices Continue to Gain Traction As Opioid Epidemic Rages On

      Stimwave Technologies has a nod from FDA and CE mark for its Freedom SCS System, which can be used to treat chronic back pain. However, the company is continuing to gain traction with strong preliminary results for its Tsunami clinical trial. The results come at a time when the State of Oklahoma has a multi-billion case against Johnson & Johnson over the impact of the opioid crisis.

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    3. Powder-Delivery Device Approved for First and Only Nasally Administered Glucagon | MDDI Online

      Powder-Delivery Device Approved for First and Only Nasally Administered Glucagon | MDDI Online

      A ready-to-use nasal drug delivery device for powder formulations is being used for Eli Lilly’s Baqsimi, which the drug maker calls the first and only nasally administered glucagon. FDA just approved the one-step, needle-free treatment for severe hypoglycemia in people with diabetes ages four years and above, the company reported.

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    4. How to Keep Up with FDA’s Expanding UDI Requirements

      How to Keep Up with FDA’s Expanding UDI Requirements

      Patient safety doesn’t just lie in the hands of doctors and nurses. Medical devices and surgical instruments also have a huge impact on the accuracy of diagnostics and the proper execution of treatment plans. The reliability of devices used to treat or diagnose patients can be a matter of life or death, and flaws might not become apparent until it’s too late.

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      Mentions: Jorg Lorscheider
    5. 9 Promising Cardio Technologies

      9 Promising Cardio Technologies

      Heart disease kills well over half a million Americans each year, making it the leading cause of death in both men and women, according to the CDC. This healthcare crisis poses a huge—and very expensive—challenge for the healthcare system, and medical device makers are stepping up to meet it.

      These nine technologies are just some of the breakthroughs we've seen recently in the cardio realm.

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    6. Survey: Device Tax Suspension Lifting Hiring, R&D

      Survey: Device Tax Suspension Lifting Hiring, R&D

      A small survey finds that the medtech industry is already benefiting from the suspension of the medical device tax. Learn how executives say they're investing the savings.

      It's only been six months, but the device tax suspension is already doing good. That's what medical device executives told the Medical Imaging and Technology Alliance during a survey the medical imaging technology industry group conducted this spring.

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      Mentions: Jorg Lorscheider
    7. Effective Product Lifecycle Management for Medical Devices | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

      Effective Product Lifecycle Management for Medical Devices | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

      RFID tracking can help medical device manufacturers prevent counterfeiting, ensure cleaning and sterilization protocols are followed, and ensure recalls go smoothly.  In recent months and years, the need for vigilance around product lifecycle management (PLM) for medical devices has become increasingly clear.

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      Mentions: Jorg Lorscheider
    8. FDA's Patel: Time for a Paradigm Shift in Software Review

      FDA's Patel: Time for a Paradigm Shift in Software Review

      Recognizing the fast pace of advancement in software development, FDA is searching for the best way to regulate higher-risk medical software products. The tricky part of oversight comes in trying ensure safety while maintaining a rapid pace of innovation.

      'Can we re-look at the paradigm and see—what is the best way to review and have oversight of software? Because it's not physical. It changes fast. It iterates faster than any other product we know in the physical world,' said Bakul Patel, associate director for digital health at FDA, during the MD&M East Conference this week in New York City.

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    9. Healthcare Needs an Elon Musk

      Healthcare Needs an Elon Musk

      We need someone like the billionaire businessman behind Tesla Motors and SpaceX to tackle the massive problems faced by healthcare systems today.

      We’re not even halfway through the calendar, and already 2016 has been a historic year for billionaire businessman Elon Musk. When Tesla Motors, the electric vehicle company he founded and leads, unveiled its Model 3 car in March, orders shot to nearly a quarter million within 24 hours.

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      Mentions: Jorg Lorscheider
    10. FDA Updates IDE Device Categorization for CMS Coverage

      FDA Updates IDE Device Categorization for CMS Coverage

      For more than two decades, FDA has been categorizing investigational medical devices as either Category A (experimental/investigational) or Category B (non-experimental/investigational) based on the device risk level. This matters because CMS uses that categorization to determine whether the device receives Medicare coverage or not. Typically, this means that CMS will cover device expenses for a Category B IDE device study but not a Category A IDE study.

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    11. 3 Takeaways About J&J's Devices Business Transformation | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

      3 Takeaways About J&J's Devices Business Transformation | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

      Investors haven't been too happy with Johnson & Johnson lately with reports of the company getting hit with requests to ramp up its acquisitions and to break up its various businesses.

      Yet, according to recent analyst reports based on an analyst meeting that J&J held Wednesday in New Jersey, the company has been quietly rejiggering its operations, shoring up its strengths and innovating to breathe new life its consumer and medical device business.

      Here are five takeaways about the device business of the diversified conglomerate — both consumer facing and hospital facing.

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    1-24 of 36 1 2 »
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