Healthcare Equipment and Supplies
Company Overview of Nova Biomedical Corporation
Nova Biomedical Corporation develops, manufactures, and sells blood testing analyzers. It provides hand held point-of-care analyzers, clinical analyzers, biotech analyzers, lactate meters for athletes, self testing monitors, and hospital based blood gas and critical care analyzers; and contract development and manufacturing services. The company serves healthcare companies, including diagnostic firms. It markets and sells its products through distributors in the United States and internationally. Nova Biomedical Corporation was incorporated in 1976 and is headquartered in Waltham, Massachusetts with a manufacturing facility in Taipei, Taiwan. It has sales subsidiaries in Mississauga, Canada;...
200 Prospect Street
Waltham, MA 02454-9141
Founded in 1976
Key Executives for Nova Biomedical Corporation
Chief Executive Officer and President
Vice President of Human Resources
Vice President of Business Development
Vice President of Research & Development
Compensation as of Fiscal Year 2014.
Nova Biomedical Corporation Key Developments
The U.S. Food and Drug Administration Clears New Indication for Nova Biomedical's Nova StatStrip Glucose Hospital Meter System
Sep 24 14
The U.S. Food and Drug Administration cleared a new indication for the Nova StatStrip Glucose Hospital Meter System, extending its use to critically ill patients who have been hospitalized. This is the first blood glucose monitoring system (BGMS) cleared by FDA for use in these patients. Blood glucose monitoring systems, also called blood glucose meters, are handheld devices that measure the amount of sugar (glucose) in blood by analyzing a small drop of blood that is placed on a test strip. After inserting the test strip into the device, the system displays a glucose level reading. Blood glucose measurements are used in the management of many patients in the hospital, including patients requiring insulin to manage blood sugar, and in the assessment of blood glucose levels in newborn babies. The Nova StatStrip Glucose Hospital Meter System is the first FDA clearance of a device specifically indicated for use in all types of hospital patients, including critically ill patients. The FDA determined that the Nova StatStrip Glucose Hospital Meter System is simple to use and has a low risk for false results, and granted with the clearance 'waived' test system status under CLIA. This waived status will allow a broad variety of health care professionals, such as nurses and technicians, to perform the test at the point-of-care, such as at a patient’s bedside, instead of requiring that the test be performed in a hospital lab (or other lab) that meets the CLIA requirements for high complexity testing. The CLIA waiver will also allow hospital labs to safely provide blood glucose monitoring to their critically ill patients without having to meet the significant CLIA requirements for high complexity testing. The FDA originally cleared the Nova StatStrip Glucose Hospital Meter System in April of 2006 for use in hospitals as an aid in monitoring the effectiveness of a diabetes control program, but not for use with critically ill patients. The device manufacturer submitted a new premarket submission to the FDA seeking clearance of the device with this new indication.
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