The FDA has announced a public workshop on medical device servicing and remanufacturing, which will occur on December 10-11 in Washington, D.C. A guidance will likely be forthcoming after the workshop is completed and docket comments have been reviewed. Read more here.
The healthcare seems less concerned about hackers and more about achieving the tenets of value-based medicine. Its focus on improving patient experience and reducing cost has pushed cybersecurity down the list of spending priorities when it should be rising. The healthcare industry must be prepared for hack attacks, cybersecurity experts agree. The very essence of value-based [...]
GE also announced it "will fall short of previously indicated guidance for free cash flow and (earnings per share) for 2018," and expects to take a non-cash goodwill impairment charge related to the GE Power business. GE Power’s current goodwill balance is approximately $23 billion and the goodwill impairment charge is likely to constitute substantially [...]
If you're wondering why sometimes medical imaging devices aren't being funded, this looks like a possible reason. Hospitals spent nearly $25 billion globally on electronic health records in 2017 and that is projected to increase to $33 billion by 2023 but signs are also emerging EHR spending is starting to slow down, according to a [...]
Industry M&A may be no savior as the pace of hospital closures, particularly in hard-to-reach rural areas, seems poised to accelerate. Hospitals have been closing at a rate of about 30 a year, according to the American Hospital Association, and patients living far from major cities may be left with even fewer hospital choices as insurers [...]
The House of Representatives voted overwhelmingly Tuesday to kill a sales tax on medical devices that the medical-technology industry around the country have battled for nearly a decade. Industry insiders hope that Tuesday’s vote will provide the momentum that leads to action by the end of the year. Read more here.
June 26, 2018 —GE announced the results of its strategic review, and plans to separate GE Healthcare into a standalone company and pursue an orderly separation from BHGE over the next two to three years to make its corporate structure leaner and substantially reduce debt. GE will focus on aviation, power and renewable energy, creating [...]
This video details, Mr. Kerwin's analysis of the recent FDA report on 3rd party service. We hope you'll take the time to view it. Should you have any questions, please feel free to contact us.
The U.S. Department of Homeland Security ICS-CERT has issued cyber vulnerability advisories for the Philips Brilliance CT system, and the Silex Technology SX-500/SD-320AN and GE Healthcare MobileLink. Read more here.
Medical device recalls reached record highs in the first three months of 2018 thanks to software complications that are likely to continue with the proliferation of high-tech devices. Read more here.