neumodx secures fda emergency use authorization

Submit Demands Online

Ortho Clinical Diagnostics (Raritan N J USA) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its total antibody assay for COVID-19—the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators An emergency use authorization (EUA) in the United States is an authority granted to the Food and Drug Administration (FDA) under sections of the Federal Food Drug and Cosmetic Act as added to and amended by various Acts of Congress including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) It does not constitute approval of the drug in the full statutory

Battelle Gets FDA Emergency Use Authorization for N95

Mar 30 2020On Saturday FDA issued an Emergency Use Authorization for the Battelle's CCDS Critical Care Decontamination System for use in decontaminating compatible N95 respirators used by healthcare personnel Per the agency's letter to Battelle one N95 mask can be decontaminated up to 20 times "Based on the totality of scientific evidence available to FDA it is reasonable to believe that the

Jun 08 2020June 8 2020—NeuMoDx Molecular released software that introduces "extraction only" capabilities among other enhancements The extraction only feature provides users with an option for a faster extraction process to enhance molecular testing The NeuMoDx 288 and 96 molecular systems are capable of extracting DNA and RNA from about 400 and 200 samples in an eight-hour period

Mar 18 2020This week the FDA made a major move to increase the availability of diagnostics that can detect the COVID-19 virus during this public health emergency The agency issued Emergency Use Authorization to Hologic for its Panther Fusion SARS-COV2 Assay

Mar 23 2020FDA Issues Emergency Use Authorization for Hologic and LapCorp COVID-19 Tests The agency will continue to work with companies developing diagnostics relevant to the coronavirus outbreak in an effort to rapidly bring technologies to market

Mar 26 2020Yesterday the U S Food and Drug Administration (FDA) took action to make more ventilators available to health care personnel in the United States The FDA issued an emergency use authorization for ventilators anesthesia gas machines modified for use as ventilators and positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators") []

Formlabs Becomes First 3D Printing

Formlabs a leading 3D printing company announced today that it has received emergency use authorization (EUA) from the U S Food and Drug Administration (FDA) to print bi-level positive airway pressure (BiPAP) adapters designed by Northwell Health New York's largest healthcare provider Formlabs is the first 3D printing manufacturer to

– High throughput system provides STAT results in about 80 minutes – March 31 2020 (Ann Arbor Michigan) NeuMoDx™ Molecular a sample-to-result molecular diagnostic company focused on providing high throughput testing solutions to hospital and commercial reference laboratories announced that the U S Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for

Baird Capital portfolio company NeuMoDx Molecular which designs and develops molecular diagnostic solutions for hospital and clinical reference laboratories today announced that the U S Food and Drug Administration (FDA) has issued an Emergency Use Authorization for a COVID-19 assay (test) for use on the company's molecular systems

Apr 17 2020CirrusDx Laboratory has received emergency use authorisation from FDA for COVID-19 testing (Credit: mohamed Hassan from Pixabay) Cirrus Dx an infectious disease laboratory and diagnostics company received Emergency Use Authorization (EUA) from the US Food Drug Administration (FDA) to perform SARS-COVID-19 testing

About Emergency Use Authorization Status The cobas SARS-CoV-2 Test has not been FDA cleared or approved It has been authorized by the FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) 42 U S C 263a to perform moderate and high complexity tests

NeuMoDx Molecular (Ann Arbor MI USA) a sample-to-result molecular diagnostic company focused on providing high throughput testing solutions to hospital and commercial reference laboratories has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its NeuMoDx SARS-CoV-2 Assay that is implemented on the NeuMoDx Molecular Systems

The EUA allows for the distribution and emergency use of remdesivir only for the treatment of COVID-19 remdesivir remains an investigational drug and has not been approved by FDA The U S government will coordinate the donation and distribution of remdesivir to hospitals in

FDA Provides Emergency Use Authorization to PerkinElmer for Serological Test to Identify COVID-19 Antibodies Read More WALTHAM Mass –(BUSINESS WIRE)–May 5 2020– PerkinElmer Inc (NYSE: PKI) a global leader committed to innovating for a healthier world announced today that the U S Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for

After Remdesivir's Emergency Use Authorization US Gov't

Gilead's antiviral remdesivir will go to hospitalized severe COVID-19 patients per FDA's EUA Some cities could receive the medicine with days but it is not clear how the government will dole out the limited supplies FDA said it had access to non-public data from a key NIH trial during its EUA review

Incidentally Roche recently released their own SARS-CoV-2 assay for this system under "Emergency Use Authorization" by the FDA However taking into consideration sample registration pretreatment preparation of batches and generating reports it usually takes more than 5 h before results can be made available to clinicians [ 14 ]

Mar 30 2020On Saturday FDA issued an Emergency Use Authorization for the Battelle's CCDS Critical Care Decontamination System for use in decontaminating compatible N95 respirators used by healthcare personnel Per the agency's letter to Battelle one N95 mask can be decontaminated up to 20 times "Based on the totality of scientific evidence available to FDA it is reasonable to believe that the

Mar 26 2020Yesterday the U S Food and Drug Administration (FDA) took action to make more ventilators available to health care personnel in the United States The FDA issued an emergency use authorization for ventilators anesthesia gas machines modified for use as ventilators and positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators") []

May 14 2020The algorithm was granted FDA Breakthrough Device designation in December 2019 (Credit: Pixabay/Bokskapet) US-based digital medical devices company Eko has received the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its

May 01 2020Officials with the FDA have issued an emergency use authorization (EUA) for remdesivir (Gilead Sciences) for the treatment of suspected or laboratory-confirmed coronavirus disease 2019 (COVID-19) in hospitalized adults and children according to a press release 1 The EUA allows for remdesivir to be distributed in the United States and administered intravenously by health care

Mar 13 2020The U S Food and Drug Administration (FDA) granted Roche's cobas SARS-CoV-2 Test Emergency Use Authorization Hospitals and laboratories will be able to run the test on Roche's fully automated cobas 6800 and cobas 8800 Systems which are already in wide use

May 05 2020WALTHAM Mass --(BUSINESS WIRE)--May 5 2020-- PerkinElmer Inc (NYSE: PKI) a global leader committed to innovating for a healthier world announced today that the U S Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for EUROIMMUN's (a PerkinElmer company) Anti-SARS-CoV-2 ELISA (IgG) serology test Clinical laboratories certified to

Gilead's antiviral remdesivir will go to hospitalized severe COVID-19 patients per FDA's EUA Some cities could receive the medicine with days but it is not clear how the government will dole out the limited supplies FDA said it had access to non-public data from a key NIH trial during its EUA review

Mar 26 2020The FDA issued an emergency use authorization for ventilators anesthesia gas machines modified for use as ventilators and positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators") ventilator tubing connectors and

Mar 27 2020Morrison Foerster secured an Emergency Use Authorization (EUA) from the U S Food Drug Administration (FDA) for client BGI Genomics for its Real-Time SARS-CoV-2 Test in under two weeks BGI's Real-Time SARS-CoV-2 Test detects novel coronavirus with high sensitivity and a three hour turnaround time

DANVERS Mass --(BUSINESS WIRE)--The United States Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Impella RP to include patients suffering from COVID-19 related right heart failure or decompensation including pulmonary embolism (PE) Abiomed (NASDAQ: ABMD) manufactures Impella RP Impella RP is a temporary heart pump that provides circulatory