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ICU Medical, Inc.

http://www.icumed.com/

Latest From ICU Medical, Inc.

FDA Warns Lymol To Assess Talc Lead Risk Per ICH Q3D; Puts Others On Notice

A warning letter to firm with legacy talc drug product puts pharmaceutical industry on notice: the US FDA expects applicants to meet requirements agency imposes post-approval for matters like elemental impurities compliance.

Enforcement Quality

MTI 100: Major M&A Bookends Year Of Mainly Steady Growth For Leading Medtech Groups

In Medtech Insight's latest rankings of top 100 revenue-earners in the medical device and diagnostics sector, it was steady as she goes for most of the multinational medtechs, with some major exceptions. But there will be more M&A reflected in next year's ranking based on 2018 revenues. Also, medtech groups leading the global market tightened their grip further in 2017, as providers chose to partner more and more with fewer suppliers who can offer a wider provision of services.

Commercial M & A

As Saline Shortages Persist, Providers Pin Hopes On Feds Demanding Backup Manufacturing Capacity

As market forces, seasonal flu and extreme weather cause US shortages of intravenous saline solutions to persist, providers writing in NEJM are heartened by idea that federal Homeland Security Department could step in to require manufacturing redundancies. Will industry solve the problem before it becomes a matter of national security?

Manufacturing Compliance

'Qui Tam' Suit Says Hospira Billed Government For Faulty Infusion Pumps

A newly unsealed whistleblower suit filed in Illinois federal court in 2016 alleges the company failed to alert US FDA or customers to software and power cable issues that could have harmed patients and users. Pfizer, which purchased Hospira in 2015 and sold the infusion pump unit in 2017, says the case has no merit, and the government has declined to intervene.

Legal Issues Quality Control
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Company Information

  • Industry
  • Medical Devices
    • Infusion Therapy Equipment and Supplies
    • Monitoring Equipment & Devices
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