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Magellan Biosciences Inc.

Latest From Magellan Biosciences Inc.

BD Handed US FDA Warning Letter In Lead-Test Investigation

The agency letter cites quality systems, Medical Device Reporting and device clearance concerns. It stems from an ongoing investigation into lead tests distributed by Magellan Biosciences that sometimes give faulty results.

Quality Control Regulation

US FDA: BD Didn't Document Faulty Lead-Test Warning

An FDA-483 released as part of an ongoing probe into Magellen’s faulty LeadCare tests found potential GMP and Medical Device Reporting violations at a BD location.

Medical Device Diagnostics

US FDA: Magellan Failed To Ensure Lead Test Accuracy

A US FDA Form-483 inspection report form shows GMP, complaint handling and Medical Device Reporting violations at the Massachusetts facility of Magellan, which is facing serious scrutiny over lead test mishaps.

Medical Device In Vitro Diagnostics

Device/Diagnostics Quarterly Deal Statistics, Q1 2016

Device companies raised 50% more in Q1 2016 than the previous quarter, reaching $1.8 billion and led by debt offerings; diagnostic imaging acquisitions, such as Toshiba Medical Systems, were abundant. Diagnostics financings double in Q1, mostly from venture funding, including strong showing from liquid biopsy companies.

Medical Device Market Intelligence
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Company Information

  • Industry
  • Biotechnology
  • In Vitro Diagnostics
    • Chemistry, Immunoassay
  • Pharmaceuticals
  • Research, Analytical Equipment & Supplies
  • Therapeutic Areas
  • Non-Specific
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Magellan Biosciences Inc.
  • Senior Management
  • Hossein Maleknia, COO
    Amy Winslow, President
    Peter Glick, COB
    Robb Morse, Global Director, Marketing
    Norman Sheppard, VP, R&D
    Janine LeBlanc, Director, Finance
  • Contact Info
  • Magellan Biosciences Inc.
    Phone: (978) 856-2345
    101 Billerica Ave
    Bldg 4
    North Billerica, MA 01862