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Nova Biomedical Corp.

Latest From Nova Biomedical Corp.

ADA2018: Senseonics' Implantable CGM Beats Abbott, Dexcom In Head-To-Head Study – But Is Methodology Flawed?

In a three-way patient study comparing the accuracy of three currently available continuous glucose monitoring (CGM) devices, the newly FDA-approved Eversense by Senseonics performed significantly better than the Abbott Freestyle Libre Pro and Dexcom G5. The study findings were presented during this year's annual American Diabetes Association meeting in Orlando, Florida. This article also discusses other highlights presented by the three companies at the ADA conference.

Diabetic Care Clinical Trials

FDA Panel Sheds More Light On Glucose Meter Use In Hospitals, But Much Left Unanswered

While finger-prick blood glucose meters are cleared for at-home use, US FDA is still struggling with requirements for clearing such products to support treatment of patients in hospital intensive care settings. To help get clarity, the agency recently asked a panel of experts to provide advice.

Advisory Committees Diabetic Care

US FDA Panel To Tackle Hospital Glucose Meter Accuracy Issue

FDA says it has become aware of large data sets that raise new questions about the level of accuracy that blood glucose meters can deliver in an intensive-care hospital setting using capillary blood samples. An advisory panel will be tasked March 30 with considering the issue and its impact on assessing risk-benefit of the devices in the hospital environment.

Advisory Committees Diabetic Care

FDA Tempers Accuracy Standards For Hospital Glucose Meters In Final Guidance

The US agency finalized two closely watched guidance documents for blood glucose systems used in the hospital and at home. The guidance focusing on hospital point-of-care systems included a key revision of proposed accuracy standards from a 2014 draft guidance that had been broadly maligned as too tough.

Policy & Regulation Regulation
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Company Information

  • Industry
  • Medical Devices
  • Therapeutic Areas
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Nova Biomedical Corp.
  • Senior Management
  • Frank Manganaro, Pres. & CEO
    John J Wallace, VP, Operations & CFO
  • Contact Info
  • Nova Biomedical Corp.
    Phone: (781) 894-0800
    200 Prospect St.
    Waltham, MA 02254-9141