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Navilyst Medical Inc.

Division of AngioDynamics Inc.
www.navilystmedical.com

Latest From Navilyst Medical Inc.

Warning Letter Close-Outs – December 2015

Ten FDA close-out letters were released in December.

Medical Device Regulation

Warning Letter Roundup & Recap

US Infusion didn’t report complaints of leaking IV sets to FDA as Medical Device Reports; quality system deficiencies noted at two Navilyst Medical facilities; maker of patient treatment chairs failed to notify FDA after initiating a product recall. Eight quality-related warning letters were listed by FDA from Nov. 12 through Dec. 17.

Medical Device

New Product Briefs: 510(k)s for bioMérieux, Navilyst Medical and Novo Nordisk

FDA clears bioMérieux’s Vitek MS system for rapid identification of disease-causing bacteria and yeast in human specimens. Navilyst Medical introduces a second BioFlo device with Endexo thrombus-resistance. More new products.

AngioDynamics Gains AngioVac Clot Remover In $55 Mil. Vortex Acquisition

Deal strengthens peripheral vascular product offerings with the addition of 510(k)-cleared blood clot removal system, which AngioDynamics expects will generate $50 million in annual sales in five years.

Medical Device Deals
See All

Company Information

  • Industry
  • Medical Devices
    • Implantable Devices
    • Surgical Equipment & Devices
      • Minimally or Less Invasive
  • Therapeutic Areas
  • Cardiovascular
  • Renal System
  • Alias(es)
  • Ownership
  • Private
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • AngioDynamics Inc.
  • Senior Management
  • Ron Sparks, Chmn. & CEO
  • Contact Info
  • Navilyst Medical Inc.
    Phone: (508) 658-7990
    26 Forest St.
    Marlborough, MA 01752
    USA
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