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Nova Biomedical New Generation StatStrip Glucose Hospital Meter Obtains FDA 510k Clearance

By: PRLog

WALTHAM, Mass. - March 25, 2024 - PRLog -- Nova Biomedical announces the U.S. launch of our New Generation StatStrip Glucose Hospital Meter System. The new meter includes many features that make hospital glucose testing easier and more cybersecure while retaining the accuracy, freedom from interferences, and FDA clearance for use with critically ill patients that StatStrip has provided for the last decade.

The new StatStrip meter uses the same proven test strip that is still the only FDA-cleared test strip for glucose testing of critically ill patients. Over 200 clinical studies have been published confirming StatStrip's accurate results with no interference from drugs (over 8,000 medications tested) or physiological conditions commonly found in patients in intensive care settings with complex medical conditions and drug regimens.

Important new meter features provide easier and more secure bedside glucose testing:

  • Linux® operating system with enhanced cybersecurity
  • Wireless charging
  • RFID data entry
  • Rugged external meter casing
  • Sealed battery casing
  • Cleaning and disinfection clearance for Clorox Bleach and Super-Sani Wipes
  • Hematocrit range extended to 5% to 75%
Nova chose to move to Linux OS for its next-generation meter operating system due to its enhanced security against viruses and other malware. Wireless meter charging provides faster, easier, and safer meter charging in a smaller package. The battery is charged in the meter's sealed compartment, and the charger automatically shuts off when the meter is fully charged. StatStrip users can now easily enter operator ID and patient ID using RFID, an illuminated barcode scanner, or touchscreen keyboard entry. To meet the challenges of occasional rough meter use and repeated exposure to harsh disinfecting agents, StatStrip's new meter casing uses a unique soft-touch over-molding material.

"We are proud to now offer our StatStrip New Generation platform for glucose testing," said Rick Rollins, StatStrip Product Manager. "The new meter gives current StatStrip users and non-users a clear upgrade for easier hospital glucose testing while ensuring accurate, interference-free, and safe use with critically ill patients."

About Nova Biomedical

Incorporated in 1976 and based in Waltham, MA, Nova Biomedical is a world leader in the development and manufacturing of whole blood, point-of-care and critical care analyzers, as well as instruments for cell culture monitoring in the biotechnology market. Nova uses biosensor technology in products ranging from handheld meters for glucose self- and point-of-care testing to critical care whole blood analyzers designed for stat measurement of over 24 analytes. Nova's BioProfile line has pioneered comprehensive cell culture testing, providing over 20 critical cell culture tests for a broad range of cell culture applications. Nova employs over 1,500 people worldwide and has wholly owned subsidiaries located in Australia, Benelux, Brazil, Canada France, Germany, Great Britain, Italy, Japan, Spain, and Switzerland. Certified by the International Organization for Standardization, Nova has manufacturing operations located in the U.S. and Taiwan.

Richard Rollins

Photos: (Click photo to enlarge)

Nova Biomedical Logo Next-generation StatStrip Glucose Hospital Meter

Source: Nova Biomedical

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