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  • FDA authorizes Marketing of new Device designed to remove Dead Pancreatic Tissue

    FDA authorizes Marketing of new Device designed to remove Dead Pancreatic Tissue

    U.S. Food and Drug Administration authorizes Marketing of new Device designed to remove Dead Pancreatic Tissue | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 23, 2020) Today, the U.S. Food and Drug Administration authorized marketing of the EndoRotor System to resect (cut out) and remove necrotic (dead) tissue for patients with walled-off pancreatic necrosis (WOPN), a potentially deadly condition which can occur several weeks after an episode of severe acute pancreatitis, often requiring tissue removal. “This device has shown its potential to provide a minimally invasive way to remove harmful necrotic pancreatic tissue in patients with walled-off pancreatic necrosis, which occurs in about 15 percent of patients with severe pancreatitis,” said Charles Viviano, M.D., Ph.D., acting director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the FDA’s Center for ...
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  • FDA Authorizes Marketing of New Implant to Repair a Torn ACL

    FDA Authorizes Marketing of New Implant to Repair a Torn ACL

    U.S. Food and Drug Administration Authorizes Marketing of New Implant to Repair a Torn ACL | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 16, 2020) Today, the U.S. Food and Drug Administration granted marketing authorization—under the De Novo premarket review pathway—for an anterior cruciate ligament (ACL) implant, intended to serve as an alternative to ACL reconstruction to treat ACL tears. The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL repair and is the only currently- available alternative to reconstruction with allograft, autograft or suture-only repair for the treatment of ACL rupture. “Torn ACLs are among the most common knee injuries in the U.S., but for years, treatment has been limited to ACL reconstruction, which can be quite invasive and typically requires using tendon or a combination of tendon...
    See more | Go to post

  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - FDA Authorizes First Direct-to-Consumer COVID-19 Test System

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes First Direct-to-Consumer COVID-19 Test System | site |


    Test system is authorized for at-home sample collection with laboratory test processing


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 9, 2020) Today, the U.S. Food and Drug Administration authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription. This product, which is authorized as the first COVID-19 direct-to-consumer (non-prescription) test system, allows an individual to self-collect a nasal swab sample at home and then send that sample for testing to LabCorp. Positive or invalid test results are then delivered to the user by phone call from a health care provider. Negative test results are delivered via email or online portal. This home sample collection kit can be purchased online or in ...
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  • FDA Coronavirus COVID-19 Update - - - FDA Authorizes First COVID-19 and Flu Combination Test for use with Home-collected Samples

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 and Flu Combination Test for use with Home-collected Samples | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 4, 2020) Today, the U.S. Food and Drug Administration authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu). The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider. Under a health care provider’s order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collec...
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  • FDA Coronavirus COVID-19 Update - - - FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 | site |


    (Information contained in U.S. Food and Drug Administration (FDA) press release: November 21, 2020)

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions. In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for di
    ...
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  • Coronavirus COVID-19 Update - - - FDA Authorizes Drug Combination for Treatment of COVID-19

    Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19 | site |



    (Information contained in U.S Food and Drug Administration [FDA] press release: November 19, 2020)


    November 19, 2020


    Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In a clinical trial of hospitalized patients with COVID-19, baricitinib, in combination with remdesivir, was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo w...
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  • FDA Coronavirus COVID-19 Update - - - FDA Authorizes First COVID-19 Test for Self-Testing at Home

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home | site |




    (November 17, 2020) - - On November 17, 2020 the U.S. Food and Drug Administration (FDA) published the following information:

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. “The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic
    ...
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  • Coronavirus COVID-19 Update - - - FDA Authorizes Monoclonal Antibody for Treatment of COVID-19

    Coronavirus (COVID-19) Update: U.S. Food and Drug Administration Authorizes Monoclonal Antibody for Treatment of COVID-19 | site |



    (November 9, 2020) - - On November 9, 2020 the U.S. Food and Drug Administration (FDA) published the following information:

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions. While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivima
    ...
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  • Coronavirus - - COVID-19 - - Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection

    Coronavirus (COVID-19) Update: FDA Authorizes First Test that Detects Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection| site |


    (November 6, 2020) - - On November 6, 2020 the U.S. Food and Drug Administration (FDA) published the following information:

    Today, the U.S. Food and Drug Administration authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells. The FDA issued an emergency use authorization (EUA) for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which specifically detects this type of antibody. Although the FDA has previously issued EUAs to more than 50 antibody (serology) tests, those tests only detect the presence of binding antibodies. Binding antibodies bind to a pathogen, such as a virus, but ...
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  • U.S. Food and Drug Administration Authorizes Emergency Use of First Ebola Fingerstick Test with Portable Reader

    U.S. Food and Drug Administration Authorizes Emergency Use of First Ebola Fingerstick Test with Portable Reader



    (November 9, 2018) - - The U.S. Food and Drug Administration published (today) the following information:

    Today, the U.S. Food and Drug Administration announced that an emergency use authorization (EUA) has been issued for a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus). This is the second Ebola rapid antigen fingerstick test available under EUA, but the first that uses a portable battery-operated reader, which can help provide clear diagnostic results outside of laboratories and in areas where patients are likely to be treated. The test, called the DPP Ebola Antigen System, is used with blood specimens, including capillary “fingerstick” whole blood, from individuals with signs and symptoms of Ebola virus disease (EVD) in addition to
    ...
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  • Federal Communications Commission Authorizes SPACEX to Provide Broadband Services via Satellite Constellation

    Federal Communications Commission Authorizes SPACEX to Provide Broadband Services via Satellite Constellation


    April 3, 2018



    Washington, DC - - (March 29, 2018) - - The Federal Communications Commission (FCC) approved an application by Space Exploration Holdings, doing business as SpaceX, to provide broadband services using satellite technology in the United States and around the world. With this action, the Commission takes another step to increase high-speed broadband availability and competition in the United States. This is the first approval of a U.S.-licensed satellite constellation to provide broadband services using a new generation of low-Earth orbit satellite technologies. SpaceX proposed a satellite system comprised of 4,425 satellites and was granted authority to use frequencies in the Ka (20/30 GHz) and Ku (11/14 GHz) bands to provide global Internet connectivit
    ...
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  • Court Authorizes Service of John Doe Summons Seeking the Identities of U.S. Taxpayers Who Have Used Debit Cards in Furtherance of Tax Evasion

    Court Authorizes Service of John Doe Summons Seeking the Identities of U.S. Taxpayers Who Have Used Debit Cards in Furtherance of Tax Evasion




    January 26, 2017


    Washington, DC - - (January 25, 2017) - - Today a federal court in Montana unsealed an order authorizing the Internal Revenue Service (IRS) to serve a John Doe summons on Michael Behr of Bozeman, Montana, seeking information about U.S. taxpayers who may hold offshore accounts established by Sovereign Management & Legal LTD (SML), a Panamanian entity. Specifically, the IRS is seeking records of U.S. taxpayers who, during the years 2005 to 2016, had been issued a “Sovereign Gold Card” debit card that could be used to access the funds in those accounts in such a manner as to evade their obligations under internal revenue laws. The IRS uses John Doe summonses to obtain information about possible violations of internal revenue laws by individuals whose identities are unknown.
    ...
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  • Staff Reporter 1
    FDA authorizes Marketing of new Device designed to remove Dead Pancreatic Tissue
    by Staff Reporter 1
    U.S. Food and Drug Administration authorizes Marketing of new Device designed to remove Dead Pancreatic Tissue | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 23, 2020) Today, the U.S. Food and Drug Administration authorized marketing of the EndoRotor System to resect (cut out) and remove necrotic (dead) tissue for patients with walled-off pancreatic necrosis (WOPN), a potentially deadly condition which can occur several weeks after an episode of severe acute pancreatitis, often requiring tissue removal. “This device has shown its potential to provide a minimally invasive way to remove harmful necrotic pancreatic tissue in patients with walled-off pancreatic necrosis, which occurs in about 15 percent of patients with severe pancreatitis,” said Charles Viviano, M.D., Ph.D., acting director of the Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors Office in the FDA’s Center for ...
    12-24-2020, 10:08 AM
  • Staff Reporter 1
    FDA Authorizes Marketing of New Implant to Repair a Torn ACL
    by Staff Reporter 1
    U.S. Food and Drug Administration Authorizes Marketing of New Implant to Repair a Torn ACL | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 16, 2020) Today, the U.S. Food and Drug Administration granted marketing authorization—under the De Novo premarket review pathway—for an anterior cruciate ligament (ACL) implant, intended to serve as an alternative to ACL reconstruction to treat ACL tears. The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL repair and is the only currently- available alternative to reconstruction with allograft, autograft or suture-only repair for the treatment of ACL rupture. “Torn ACLs are among the most common knee injuries in the U.S., but for years, treatment has been limited to ACL reconstruction, which can be quite invasive and typically requires using tendon or a combination of tendon...
    12-17-2020, 03:06 AM
  • Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - FDA Authorizes First Direct-to-Consumer COVID-19 Test System
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes First Direct-to-Consumer COVID-19 Test System | site |


    Test system is authorized for at-home sample collection with laboratory test processing


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 9, 2020) Today, the U.S. Food and Drug Administration authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription. This product, which is authorized as the first COVID-19 direct-to-consumer (non-prescription) test system, allows an individual to self-collect a nasal swab sample at home and then send that sample for testing to LabCorp. Positive or invalid test results are then delivered to the user by phone call from a health care provider. Negative test results are delivered via email or online portal. This home sample collection kit can be purchased online or in ...
    12-10-2020, 07:25 AM
  • Staff Reporter 1
    FDA Coronavirus COVID-19 Update - - - FDA Authorizes First COVID-19 and Flu Combination Test for use with Home-collected Samples
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 and Flu Combination Test for use with Home-collected Samples | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 4, 2020) Today, the U.S. Food and Drug Administration authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu). The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider. Under a health care provider’s order, patients can collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collec...
    12-05-2020, 08:02 AM
  • Staff Reporter 1
    FDA Coronavirus COVID-19 Update - - - FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 | site |


    (Information contained in U.S. Food and Drug Administration (FDA) press release: November 21, 2020)

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions. In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for di
    ...
    11-23-2020, 09:00 AM

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