Search Results for 'test'

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• Diagnostics
  

  Fully Automated BD Phoenix CPO Detect Test Receives FDA Clearance

  New test helps hospitals more quickly identify and treat emerging antibiotic-resistant bacteria.

  PR Newswire 01.08.19
  

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• Diagnostics
  

  Imminent Release of the World's First Saliva Test for Malaria

  The SMAART detection tool works by detecting a novel biomarker for Plasmodium falciparum parasites.

  Montpellier PR 01.03.19
  

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• Diagnostics
  

  Study: New Epigenetic Cervical Cancer Test Has 100 Percent Detection Rate

  The new test was significantly better than either the Pap smear or HPV test.

  Queen Mary University of London 12.17.18
  

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• Diagnostics
  

  FDA Grants Breakthrough Device Designation to Siemens Healthineers’ ELF Test

  The company is collaborating with Gilead Sciences as part of its work to seek clearance of the test.

  Siemens Healthineers 11.09.18
  

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• Diagnostics
  

  FDA OKs First NGS Test to Spot Residual Blood Cancer Cells

  ClonoSEQ assay detects minimal residual disease in patients with acute lymphoblastic leukemia or multiple myeloma.

  U.S. Food and Drug Administration 10.01.18
  

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• Packaging & Sterilization | Testing
  

  Five Aspects of the ISO 11737-1:2018 Updates You Need to Know

  What medical device manufacturers need to know about the recent changes to the ISO bioburden standard.

  Martell Winters, Director of Scientific Competency, and Wendy Wangsgard, Ph.D., Senior Scientist—Nelson Laboratories 07.23.18
  

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• Diagnostics
  

  FDA OKs T2 Biosystems' Rapid Sepsis Test

  First FDA-cleared test to identify sepsis-causing bacteria direct from whole blood.

  GlobeNewswire 05.30.18
  

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• Digital Health | Electronics | Software & IT | Testing
  

  Coexistence Testing for Wireless Medical Devices: A Guide to Ensuring Reliable Systems

  With mobile medtech in healthcare facilities and the home, OEMs must ensure interference is not a cause for concern.

  Online Exclusives Ashton Hainge, Consultant, Intertek 08.02.17
  

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• Diagnostics
  

  FDA Clears First-Ever Fentanyl Urine Drug Screening Test

  Fentanyl enzyme immunoassay brings high-performance qualitative screening to a wide range of healthcare settings.

  Immunalysis Corporation 07.31.17
  

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• Contract Manufacturing | Materials | R&D & Design | Testing | Tubing & Extrusion
  

  Testing the Medical Device Testers

  A host of new and upcoming compliance requirements not only pose a challenge for medical device makers, but to their contract testing partners as well.

  Mark Crawford, Contributing Writer 03.13.14
  

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