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November 20, 2017

Manufacturer News

  • GE Healthcare receives Carequality Certification
  • Medtronic Announces FDA Approval and U.S. Launch of Next Generation Pacemakers
  • Facing saline shortage, FDA prioritizes some Puerto Rico plants
  • Provider Services News

  • Advisory Board finalizes $1.3B deal with UnitedHealth's Optum
  • Government News

  • FDA releases new UDI guidance
  • Hospital and IDN News

  • Florida Hospital Apopka to open $203M facility
  • Lakeland Community Hospital to close at end of year
  • Stock Watch

  • Health Stocks
  • Manufacturer News
    GE Healthcare receives Carequality Certification
    GE Healthcare received Carequality certification to enable seamless data sharing by its ambulatory EHR customers with thousands of hospitals, physician practices, payer networks, vendors, and consumer services nationally. Beyond meeting the criteria to participate in the Carequality Interoperability Framework, which include legal, policy and technical qualifications for interoperability, the company has achieved effective integration of connected data and data exchange processes into clinician workflows by introducing Centricity Healthcare Connections Hospital Connect for Centricity Practice Solution and Centricity EMR customers.
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    Medtronic Announces FDA Approval and U.S. Launch of Next Generation Pacemakers
    Medtronic plc (Dublin, Ireland) received FDA approval and announced U.S. commercial launch for its portfolio of Azure pacemakers with BlueSync technology. Available in both single-chamber and dual-chamber models, the Azure XT MRI and Azure S MRI pacemakers offer improved longevity, estimated at 13.7 years (dual chamber) or 27% longer than its predecessor, so patients likely need fewer device replacements. The new pacemakers also allow patients to have MRI scans in either 1.5 or 3 Tesla machines. In tandem with the approval of these new pacemakers, the Medtronic Percepta portfolio of quadripolar, MR-conditional cardiac resynchronization therapy pacemakers (CRT-Ps) also now includes BlueSync technology for secure, wireless remote monitoring via the Medtronic CareLink Network.
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    Facing saline shortage, FDA prioritizes some Puerto Rico plants
    "U.S. drug regulators say they’ll move some “critical facilities” that make saline bags to the front of the line for access to Puerto Rico’s still-fragile electrical grid, in an attempt to alleviate a U.S. shortage of the critical medical supply...
    "Baxter International Inc. is the biggest U.S. supplier of small saline bags, and the company’s Puerto Rico plants lost power in the storm. The Food and Drug Administration, which is monitoring the supply of dozens of drugs made in Puerto Rico, said Baxter’s facilities will get priority access to the grid in order to try and keep supplies flowing.
    "As of Monday, Baxter said that all but one plant in Puerto Rico now had grid power. But the FDA, in a statement, said that even factories back on the grid face interruptions in power..."
    Click here to read the rull article.
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    Provider Services News
    Advisory Board finalizes $1.3B deal with UnitedHealth's Optum
    Advisory Board shareholders approved a deal to sell the company's healthcare division to UnitedHealth Group's (Minnetonka, MN) Optum arm for $1.3 billion. Under the transaction, Optum will acquire Advisory Board and Advisory Board will sell its education business to Vista Equity Partners for $1.55 billion prior to the closing of the deal with Optum
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    Government News
    FDA releases new UDI guidance
    The FDA issued final guidance on direct marking of the UDI on devices. By law, a device must be directly marked with a UDI when the device is intended to be used more than once and intended to be reprocessed before each use. However, "intended to be used more than once" and "intended to be reprocessed" are not defined in the UDI regulations. The guidance provides the FDA's interpretation of these terms, clarifies when direct marking of devices with a UDI is required, provides recommendations for how labelers should comply with the UDI direct marking requirements, and clarifies the criteria for exceptions to the direct marking requirement. Click here to read more.
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    Hospital and IDN News
    Florida Hospital Apopka to open $203M facility
    Florida Hospital Apopka will open its $203 million, seven-story facility December 5. The new 320,000-square-foot building will house 120 inpatient rooms, an emergency department, two catheterization labs, and a 24-hour ICU. The facility will also provide imaging services, urology services, radiology care, and outpatient rehabilitation. The construction for the new facility took roughly two years to complete.
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    Lakeland Community Hospital to close at end of year
    Lakeland Community Hospital (Haleyville, AL), a 59-bed hospital, plans to close by the end of 2017. Approximately 87 employees will be affected by the closure. All employees will continue to receive pay and benefits until the hospital shuts down. Lakeland Community Hospital will be the sixth rural hospital in Alabama to close since 2010.
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    Stock Watch
    Health Stocks

    Quotes last updated at 11/20/2017 12:02:54 PM EST

    MMM3M COMPANY233.14+3.78Analyze
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    BAXBAXTER INTL INC63.97+0.09Analyze
    BDXBECTON DICKINSON221.66+1.35Analyze
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    BMYBRISTOL MYERS SQ60.41-0.91Analyze
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    DYIIDYNACQ HEALTHCARE0.04500.0000Analyze
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