Nova Biomedical Press Releases

FDA Clears Nova’s Stat Profile Prime Plus Analyzer for Micro Capillary Sample Mode

Nova Biomedical is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for a micro capillary sample mode on the Stat Profile Prime Plus® Critical Care analyzer. ... Details

Nova Blood Gas Analyzers Add Important New Test: Mean Corpuscular Hemoglobin Concentration (MCHC)

Nova Biomedical announces the addition of another important critical care parameter to its Stat Profile Prime Plus blood gas analyzer—the ability to rapidly calculate and report mean corpuscular hemoglobin concentration (MCHC). MCHC is a measure of the hemoglobin concentration in a given volume of packed red blood cells... Details

Nova Biomedical Continues International Expansion with New Subsidiary in Benelux

Nova Biomedical is pleased to announce the opening of a new sales, service, and distribution subsidiary in Benelux. The new facility demonstrates Nova’s continued growth in the European market and the expansion of Nova’s biotechnology and clinical products in Belgium, the Netherlands and Luxembourg... Details

Nova Biomedical FLEX2 Cell Culture Analyzer Adds Sample Retain Capability

Nova Biomedical announces the addition of a Sample Retain Collector (SRC) for BioProfile FLEX2 cell culture analyzer. The FLEX2 automated cell culture analyzer measures up to 16 tests including pH, gases, metabolites, osmolality, cell density, and cell viability ... Details

Nova StatStrip Glucose Hospital Meter System Receives License from Health Canada for Intensive Care Use

Mississauga, ONT - Nova Biomedical’s StatStrip Glucose Hospital Meter System is the first blood glucose monitoring system to be specifically approved by Health Canada for use throughout all hospital and all professional healthcare settings, including intensive care settings... Details

Nova Biomedical Launches Allegro PT/INR Test in CE Mark Countries

Nova Biomedical announces the addition of PT/INR testing for its Allegro capillary blood analyzer for point-of-care (POC) testing in primary care settings. Now with the ability to test for clotting disorders and monitor the effectiveness of blood-thinning medications, the Allegro and its StatStrip-A companion meter provide 18 clinically important tests to help physicians make therapeutic decisions and adjustments at the point-of-care. The Allegro analyser and this new PT/INR test are available now for purchase in CE regulated countries... Details

Stat Profile Prime Plus Analyzer Receives FDA Clearance for Point-of-Care Use

Nova Biomedical today announced the U.S. Food and Drug Administration (FDA) has cleared its Stat Profile Prime Plus critical care blood gas analyzer for point-of-care (POC) use. This clearance allows POC personnel to perform bedside critical care testing with lab-quality results in as little as one minute... Details

Nova Biomedical Launches Stat EMS Basic in CE Mark Countries
Simple, fast, and accurate ambulance and emergency blood testing

Nova Biomedical is pleased to announce the launch of the Stat EMS Basic blood testing system for ambulance and emergency care in CE mark countries. Stat EMS Basic measures fingerstick capillary lactate, glucose, ketone, hemoglobin, and hematocrit in six to 40 seconds with laboratory-quality results... Details

Nova Biomedical Launches CE-Marked StatStrip Lactate, Hemoglobin, and Hematocrit Point-of-Care Meter System

Nova Biomedical announces the launch of both the StatStrip and StatStrip Xpress2 Lactate, Hemoglobin, and Hematocrit Meter Systems in all CE regulated countries. Both meters provide lactate results in only 13 seconds from a 0.6 microliter capillary blood sample, and hemoglobin and hematocrit results in 40 seconds from a 1.6 microliter capillary blood sample... Details

FDA Clears New Nova Critical Care Analyzer, Stat Profile Prime Plus: New technologies that advance and simplify testing

Nova Biomedical is pleased to announce that a new addition to the Stat Profile line of blood gas critical care analyzers, Stat Profile Prime Plus, has gained FDA clearance and is now available in the United States... Details

StatStrip Glucose Hospital Meter System Receives FDA Clearance for Capillary Testing with Critically Ill Patients: Only glucose meter FDA cleared for use with critically ill patients

Nova Biomedical is pleased to announce that the StatStrip Glucose Hospital Meter System has been cleared by the U.S. Food and Drug Administration (FDA) for fingerstick capillary testing with critically ill patients (K181043)... Details

Nova Biomedical Launches New, CE-Marked StatStrip Hemoglobin and Hematocrit Meter System

Nova Biomedical is pleased to announce the latest addition to the StatStrip line of handheld, hospital meters with the StatStrip Hemoglobin and Hematocrit Meter System (StatStrip Hb/Hct), which has gained CE mark certification and is now available in all CE regulated countries... Details

Nova Biomedical Launches New Veterinary Critical Care Analyzer Stat Profile Prime Plus VET: New technologies improve testing, animal care, and profitability

Waltham, MA – Nova Biomedical is pleased to announce the domestic and international launch of Stat Profile Prime Plus VET, the latest addition to the Stat Profile line of veterinary critical care analyzers. Prime Plus VET is the most comprehensive veterinary critical care analyzer, offering 22 critical care tests including... Details

Nova Biomedical Launches New CE-Marked Critical Care Analyzer Stat Profile Prime Plus; New technologies improve and simplify testing

Waltham, MA – Nova Biomedical is pleased to announce that a new addition to the Stat Profile line of blood gas critical care analyzers, Stat Profile Prime Plus, has gained CE mark certification and is now available in all CE regulated countries. Prime Plus features... Details

Nova Biomedical Announces BioProfile® FLEX2 Cell Culture Analyzer Integration With the ambr® 15 cell culture Microbioreactor System from Sartorius Stedim Biotech

Waltham, MA – Nova Biomedical today announced a collaboration with Sartorius Stedim Biotech (SSB) for integration of the Nova BioProfile FLEX2 comprehensive cell culture chemistry analyzer with the ambr microbioreactor system. Under the terms of the agreement, technical experts from Nova and SSB collaborated to combine the cell culture analysis capabilities of the BioProfile FLEX2 with the automated sampling functions and control software of the ambr® 15 cell culture system... Details

Nova Biomedical Collaborates with Flownamics to Enable Online Automation of Cell Culture Sampling with BioProfile FLEX2 and Seg-Flow Online Autosampler

Waltham, MA – Nova Biomedical, in collaboration with Flownamics Corporation, is pleased to announce an online automation solution for cell culture sampling and comprehensive analysis for bench-scale bioreactor cultures. Nova’s BioProfile FLEX2, with 16 key cell culture tests and maintenance-free sensors, can now be paired with the Flownamics... Details

Nova Biomedical Announces Next Generation BioProfile® FLEX2 Comprehensive Cell Culture Analyzer

Waltham, MA – Nova Biomedical announces BioProfile FLEX 2, the next addition to the BioProfile line of cell culture chemistry analyzers. BioProfile FLEX 2 incorporates Nova’s maintenance-free MicroSensor™ Card technology that eliminates sensor maintenance and maximizes workflow efficiency. BioProfile FLEX 2’s very small sample volume allows for automated cell culture analysis for small volume culture systems, such as the Sartorius Ambr® microbioreactor systems... Details

Nova Biomedical Obtains CE Mark Certification for Allegro™ Analyzer: New capillary blood analyzer for point-of-care testing in primary care settings

Waltham, MA – Nova Biomedical is pleased to announce CE mark certification for Allegro, a capillary blood analyzer for point-of-care testing in primary care settings. Allegro and its StatStrip A companion meter provide 14 clinically important tests to monitor glycemic control, assess cardiac risk with a full lipids panel, and assess kidney function. All results are ready during the patient visit, simplifying clinic workflow and producing cost savings for providers, while offering clinical benefits for patients... Details

Nova Biomedical Continues International Expansion with New Subsidiary in Brazil

Waltham, MA – Nova Biomedical is pleased to announce the opening of a new sales, service, manufacturing, and distribution subsidiary in Brazil. The new facility demonstrates Nova’s commitment to the Brazilian market and to supporting the strong growth of in vitro diagnostic testing in Brazil and Mercosur countries... Details

StatStrip Glucose Xpress 2 Hospital Meter System Receives FDA Clearance for Use with Critically Ill Patients

Waltham, MA – On January 27, 2016, the Food and Drug Administration (FDA) cleared Nova’s StatStrip Glucose Xpress 2 Hospital Meter System for use throughout all professional healthcare settings, including with critically ill patients... Details

Nova Biomedical Introduces a New Generation Veterinary Critical Care Analyzer with Stat Profile® Prime Vet

Waltham, MA – Nova Biomedical is pleased to introduce Stat Profile Prime Vet, a new generation veterinary critical care analyzer that utilizes Nova’s innovative no-maintenance sensor card technology for a smaller, faster, and less expensive analyzer... Details

Nova Biomedical Simplifies Electrolyte Testing with Next Generation Stat Profile Prime Electrolyte System

Waltham, MA – Nova Biomedical is pleased to announce that the next addition to the Stat Profile product line, Stat Profile Prime ES, has gained CE mark certification for release in CE regulated countries. Prime ES incorporates Nova Biomedical’s innovative no-maintenance sensor card technology for a smaller, faster, and less expensive electrolyte analyzer... Details

Stat Profile Prime Critical Care System Receives FDA Clearance for Point-of-Care Use

Waltham, MA – Nova Biomedical’s new generation blood gas analyzer, Stat Profile Prime, has been cleared by the U.S. Food and Drug Administration (FDA) for point-of-care (POC) use, allowing non-laboratory, POC personnel to perform bedside, critical care testing with lab-quality results... Details

Nova StatStrip Xpress Glucose Hospital Meter System Receives FDA Clearance for Use with Critically Ill Patients

Waltham, MA – On May 20, 2015, the U.S. Food and Drug Administration (FDA) cleared Nova Biomedical’s StatStrip Xpress Glucose Hospital Meter System for use throughout all hospital and all professional healthcare settings, including critically ill patients... Details

Nova StatStrip Glucose Hospital Meter System Now Offers Wireless Meter Connectivity: Only glucose meter FDA-cleared for use with all patients, including critically ill

Waltham, MA – Nova Biomedical’s StatStrip Glucose Hospital Meter System now offers bidirectional wireless connectivity to the hospital’s HIS or LIS with complete security to protect patient data... Details

Nova StatStrip Glucose Hospital Meter System Receives FDA Clearance for Intensive Care Use

Only glucose monitoring system FDA-cleared for use throughout all hospital settings, all professional healthcare settings, and all patient populations including critical care… Details

Nova Biomedical Simplifies Critical Care Testing with Next Generation Blood Gas Analyzer

Waltham, MA – Nova Biomedical simplifies critical care testing with Stat Profile Prime®, a new blood gas analyzer that combines the revolutionary micro-electronics of the consumer world with Nova’s innovative ZERØ™ maintenance cartridge technology for a smaller, faster, and less expensive critical care analyzer. Stat Profile Prime’s ZERØ™ maintenance cartridge technology consists of individual cartridges... Details

Nova to Hold Its 25th Annual Scholarship Awards Dinner and Fund Raiser on May 17th, 2014

Waltham, MA, (February 2nd, 2014) -- The Nova Scholarships were started in 1989. The Scholarship program includes two distinct scholarship funds: The Thomas Gross Scholarships, established in 1989, and the Frederick Spaziani Scholarship, established in 1992. Since the first Scholarship Awards in 1990, Nova has given a total of $1,899,000 in scholarships and awards... Details

Study Demonstrates Effective Cell Culture Control and Real-Time Adjustment of Metabolites for Improved Process Control in Development Activities

ABSTRACT: Current initiatives within the biopharmaceutical industry to adopt PAT (Process Analytical Technology) approaches in manufacturing, include activities in early process development. With adherent cell lines, online sampling for real‐time process monitoring and process adjustment is challenging due to the viscosity of the cell culture and potential blockages to sampling systems caused by microcarriers... Details

BioProfile FLEX Autosampler Aids in Significant Productivity Improvement in Genentech Study

Current industry practices for large-scale mammalian cell cultures typically employ a standard platform fed-batch process with fixed volume bolus feeding. Although widely used, these processes are unable to respond to actual nutrient consumption demands from the culture, which can result in accumulation of by-products and depletion of certain nutrients... Details

New Study Shows Lactate Plus Provides Accurate and Reproducible Measurements of Blood Lactate

Objectives: The aims of this study were to: (1) determine the validity and reliability of the Nova Biomedical Lactate Plus portable analyzer, and quantify any fixed or proportional bias; (2) determine the effect of any bias on the determination of the lactate threshold and (3) determine the effect that blood sampling methods have on validity… Details

New Study Demonstrates Nova Max Plus Meter (SMBG) Is Most Accurate Glucose Meter

Waltham, MA, (September 22, 2011) – Nova Max® Plus proved to be more accurate than other leading brand self-monitoring blood glucose meters (SMBG) in a study presented September 14th, 2011 at the European Association for the Study of Diabetes (EASD). The study was performed by the Clinical Translational Research and Innovation Center, University of Ulster,… Details

Strong Growth Prompts Nova Biomedical to Increase Manufacturing Capability With Purchase of 80,000-Square-Foot Facility

Waltham, MA, January 2011- Nova Biomedical today announced that, in response to rapid growth in its diabetes and whole blood point-of-care testing products business, it has purchased an additional 80,000 square-foot manufacturing/warehouse facility in Billerica, MA. According to Lou Borrelli, Nova Biomedical CFO, “This additional state of the art manufacturing facility will ensure that… Details

U.S. Senator Scott Brown Visits Nova Biomedical

On April 28, 2011, United States Senator Scott Brown (R. MA) visited Nova Biomedical, the largest privately held in vitro diagnostic company in the U.S. and one of the largest employers among Massachusetts medical device companies. During his visit, Senator Brown toured Nova’s 300,000 square foot manufacturing, research and development facility in Waltham, Massachusetts, and… Details

Wireless Connectivity Now Available for Nova’s Hospital Meters

Waltham, MA, March 31, 2011 – Nova Biomedical announces the availability of a wireless connectivity solution for StatStrip® Glucose and StatSensor® Creatinine meters. The Nova StatStrip Wireless Tote provides bi-directional, wireless connectivity of StatStrip or StatSensor test results and patient data to/from a Lab or Hospital Information System (LIS) and is a convenient, lightweight carrying…Details

Nova Now Helping Lifescan Users Transition to Nova StatStrip Glucose Meters and Strips

On January 14, 2011, LifeScan announced they were withdrawing from the hospital point-of-care glucose testing market in North America. The announcement provided LifeScan users with a brief, 26-month period to identify, evaluate, and implement a new partner. Nova Biomedical is prepared to help you begin now to transition to a new POC glucose partner to… Details

Nova’s Diabetes Care Products Held Not To Infringe Roche’s Claims

On July 27, 2010 - The Honorable Joseph J. Farnan of the United States District Court for the District of Delaware issued an order granting client Nova Biomedical Corporation’s motion for summary judgment of non-infringement of two patents asserted by Roche Diagnostics Operations Inc. and Corange Int’l Ltd. The Court’s order is based on the September… Details

Nova Biomedical Awarded Multi-Year Glucose Monitoring System Agreement With Premier, Inc.

Waltham, MA, January 2010 – Nova Biomedical announced it has been awarded a new multi-year glucose monitoring system agreement with Premier Purchasing Partners, the group purchasing unit of Premier, Inc. This new agreement provides Premier members access to contracts for Nova’s lab-accurate and interference-free StatStrip® Glucose technology for monitoring glucose levels in hospital patients. The… Details

Nova Biomedical’s StatStrip Xpress Glucose Meter Receives FDA CLIA Waived Designation

Waltham, MA. – Nova Biomedical’s StatStrip® Xpress™ glucose monitor has been granted CLIA-waived status from the U.S. Food and Drug Administration. StatStrip Xpress is Nova’s non-connectivity companion meter to the CLIA-waived StatStrip Hospital Glucose Meter. StatStrip Xpress can now be operated under a certificate of waiver in point-of-care settings such as ambulances and remote non-hospital locations that do not require the network capabilities of the StatStrip Hospital Glucose Meter.… Details

Nova Biomedical Corporation Triumphs in High-Stakes Trade Secret Litigation in California

Waltham, MA, December 1, 2009 – Following a three-week trial, a California federal jury on Sept. 11, 2009 awarded a complete victory to Nova Biomedical Corporation against Medtronic MiniMed, Inc., which had brought claims against Nova for misappropriation of trade secrets, breach of contract, tortuous interference and conversion. Medtronic Minimed, a subsidiary of Minneapolis-based… Details

Nova Biomedical and CCS Medical Reach Definitive Agreement for a Subsidiary of Nova Biomedical to Acquire Assets of CCS Medical’s Subsidiary, Sanvita, Inc.

Nova Biomedical and CCS Medical Reach Definitive Agreement For A Subsidiary of Nova Biomedical to Acquire Assets of CCS Medical’s Subsidiary, Sanvita, Inc. Waltham, MA. and CLEARWATER, Fla. – September 10, 2009 – Nova Biomedical Corporation, a leading developer of whole blood analyzers, and CCS Medical, Inc. a leading direct-to-consumer provider of medical supplies, today... Details

Automated Modular Analyzer Provides Fast, Comprehensive Cell Culture Analysis

A new, automated modular analyzer from Nova Biomedical provides fast, comprehensive analysis for cell culture processing. BioProfile® FLEX provides up to 15 key cell culture attributes, including glucose, lactate, glutamine, glutamate, ammonium, PCO2, PO2, pH, sodium, potassium, calcium, osmolality, cell density/viability, and phosphate in a single, easy to use workstation. This comprehensive test menu provides… Details

Nova StatStrip Glucose Analyzer Receives FDA Clearance for Neonatal Testing

Nova’s new StatStrip™ Glucose Monitor has received clearance from the U.S. Food and Drug Administration for use in neonatal testing. Severe hematocrit abnormalities are routinely found in neonates. Other glucose monitors may report an error if the hematocrit value is abnormal, StatStrip is the only glucose monitor that measures hematocrit on the strip, automatically correcting… Details

First True “No Coding” Blood Glucose Monitoring System Provides Fast, Convenient Solution for Diabetes Self-Testing

An advanced blood glucose monitoring system from Nova Biomedical provides a fast, convenient solution for diabetes self-testing. The newly released Nova Max™ system is built around patented* new technology test strips that are so precise they do not require the calibration or coding required of currently available blood glucose monitors to perform a glucose test… Details

“All-in-One” Stat Analyzer Adds Total Bilirubin to Test Menu

Nova Biomedical announces the incorporation of total bilirubin (tBil) to the comprehensive test menu on its StatProfile® Critical Care Xpress (CCX) “All-in-One” Analyzers. Bilirubin is an important indicator of liver function. Its intended use is for the adult population, and neonatal patients to be cleared soon. With the addition of total bilirubin, the CCX analyzer…Details

Nova Biomedical Announces the Availability of a new pHOx Ultra Blood Gas Critical Care Analyzer

Waltham, MA, (September 15, 2011) – Nova Biomedical announces the availability of a new blood gas critical care analyzer. pHOx Ultra analyzer offers the most comprehensive features of any whole blood, critical care analyzer. It features the broadest test menu in one analyzer, with 20 user selectable tests including pH, PCO2, PO2, SO2%, Hct, Hb,… Details

Point-of-Care Blood Glucose Monitoring System Measures and Corrects Hematocrit and Electrochemical Interferences

An advanced blood glucose monitoring system from Nova Biomedical elevates bedside glucose testing to a new level of analytical performance that approaches the quality of central laboratory testing. The Nova StatStrip™ point-of-care glucose monitor incorporates a patented* new strip technology that uses four measuring wells. Current glucose strips use only one well. Nova’s Multi-Well™ system…Details

Novation Contract Awarded to Nova Biomedical

Nova Biomedical is pleased to announce an extension of its contract to provide multi-analyte point-of-care testing instrumentation to Novation through July 31, 2009. Under the terms of the agreement, Nova Biomedical will provide our advanced series of StatProfile® Critical Care Xpress (CCX) analyzers, reagents, and consumables, and our service contracts to Novation members, associates, and… Details

StatStrip Glucose and StatSensor Creatinine Meters Now Allow Off-Line Entry of POC Test Results

StatStrip® Glucose and StatSensor™ Creatinine Meters Now Allow Off-Line Entry of POC Test Results A new software enhancement for Nova StatStrip® Glucose and StatSensor™ Creatinine point-of-care monitoring systems allows off-line entry of POC test results for immediate data capture. With the enhanced NovaNet™ instrument manager software, operators can use StatStrip touchscreen to manually enter virtually… Details

OPC Connectivity Suite Facilitates BioProfile FLEX Bi-Directional Automation and Process Integration

A new Connectivity Suite from Nova Biomedical is a complete plug and play solution for use with the BioProfile® FLEX Cell Culture Analyzer that facilitates Nova’s groundbreaking bi-directional automation and product integration. The BioProfile FLEX Connectivity Suite features complete connectivity with all OPC-compliant systems including bioreactor controllers, data historians, overall IT infrastructure, and plant manager…Details

Automated High Resolution Cell Density/Viability Analyzer at Moderate Cost

BioProfile CDV incorporates advanced, state-of-the-art technology for rapid, accurate measurement of cell density and cell viability in mammalian cell cultures. Based on the widely recognized and accepted trypan blue exclusion method, BioProfile CDV combines advanced technology in robotics, digital imaging and computer algorithms in a highly automated analyzer... Details