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Global EEG/EMG Equipment Market 2019. EEG/EMG Equipment Market Size by Types, Applications, Major Regions and Major Manufacturers including the capacity, production. IM17 Mitsar Co.Ltd. ELECTROENCEPHALOGRAPHIC PC - CONTROLLED SYSTEM “MITSAR – EEG” OPERATION MANUAL MIRN. 001 RE Saint Petersburg, 2007.

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FDA COVID-19 Update: EUA Issued for Monoclonal Antibodies

On February 9, 2021, the US FDA issued an Emergency Use Authorization (EUA) for bamlanivimab IV solution and etesevimab IV solution to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients who are 12 years of age and older weighing at least 40 kg (about 88 lbs) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This EUA includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions. In clinical trials, treatment with bamlanivimab and etesevimab significantly reduced COVID-19-related hospitalization and death compared with placebo. Safety and effectiveness of bamlanivimab and etesevimab for use in the treatment of COVID-19 continue to be evaluated. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0?utm_medium=email&source=govdelivery.

FDA Statement on Following Authorized COVID-19 Vaccines Dosing Schedules

On January 4, 2021, the US FDA issued a statement regarding the importance of following the authorized dosing schedules for COVID-19 vaccines. Although there are discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19, changes to dose or dosing schedule are not supported by adequate scientific evidence and may ultimately be counterproductive to public health. Therefore, until vaccine manufacturers have data and science supporting a change, the FDA continues to strongly recommend that healthcare providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/fda-statement-following-authorized-dosing-schedules-covid-19-vaccines.

FDA COVID-19 Update: EUA Issued for the Moderna COVID-19 Vaccine

On December 18, 2020, the US FDA issued an emergency use authorization (EUA) to Moderna for a vaccine for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients 18 years of age or older. This is the second COVID-19 vaccine to gain EUA status after meeting the statutory criteria for issuance. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid.

FDA COVID-19 Update: EUA Issued for the Pfizer-BioNTech COVID-19 Vaccine

On December 11, 2020, the US FDA issued the first emergency use authorization (EUA) to Pfizer-BioNTech for a vaccine for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients 16 years of age or older. This is the first COVID-19 vaccine to gain EUA status after meeting the statutory criteria for issuance. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19.

FDA COVID-19 Update: EUA Issued for Monoclonal Antibody Cocktail

On November 21, 2020, the US FDA issued an Emergency Use Authorization (EUA) for casirivimab intravenous solution and imdevimab intravenous solution to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients who are 12 years of age and older weighing at least 40 kg (about 88 lbs) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 and/or hospitalization. In clinical trials, patients treated with casirivimab and imdevimab were shown to have a larger viral load reduction (primary endpoint) compared with those treated with placebo. Additionally, patients at high risk for disease progression who were treated with casirivimab and imdevimab had fewer hospitalizations and emergency room visits (secondary endpoint) compared with those treated with placebo. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19.

FDA COVID-19 Update: EUA Issued for Baricitinib in Combination with Remdesivir

On November 19, 2020, the US FDA issued an Emergency Use Authorization (EUA) for baricitinib oral tablets, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib, which is sold under the brand name of Olumiant(R), is FDA-approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis. While the safety and effectiveness continue to be evaluated for use in COVID-19 treatment, baricitinib in combination with remdesivir was shown in clinical trials to reduce time to recovery within 29 days after initiating treatment compared with placebo plus remdesivir. Baricitinib is not authorized or approved as a stand-alone treatment for COVID-19, For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-combination-treatment-covid-19.

FDA COVID-19 Update: EUA Issued for Monoclonal Antibody Bamlanivimab

On November 9, 2020, the US FDA 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 who are 12 years of age and older weighing at least 40 kg (about 88 lbs). Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 and/or hospitalization. While the safety and effectiveness continue to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment compared with placebo. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibody-treatment-covid-19.

FDA COVID-19 Update: First COVID-19 Treatment

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On October 22, 2020, the US FDA approved Veklury(R) (remdesivir) IV injection for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kg (about 88 lbs) for the treatment of COVID-19 requiring hospitalization. Veklury, which is the first COVID-19 treatment to gain FDA approval, was approved based on the ACTT-1 clinical trial in which the median time to recovery was fewer days for patients treated with remdesivir plus standard of care compared with those treated with placebo plus standard of care which was a significant difference. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19.

FDA COVID-19 Update: EUA Issued for Convalescent Plasma

On August 23, 2020, the US FDA issued an Emergency Use Authorization (EUA) for convalescent plasma for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Based on scientific evidence available, the FDA concluded that convalescent plasma may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks. For the full FDA press announcement, visit the following link: https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-convalescent-plasma-potential-promising-covid-19-treatment.

FDA Guidance for Extending COVID-19 Drugs 'In-Use Time'

On August 4, 2020, the US FDA issued information regarding extending 'in-use time' for drugs needed to treat patients with COVID-19 in response to challenges faced by health care facilities and providers in maintaining adequate supplies of these drugs. In particular, health care facilities and providers have reported that care of ventilated patients can be complicated by the need to discard containers and unused portions before drugs are fully administered because of the in-use time specified on the FDA-approved label. The 'in-use time' is the maximum amount of time that can be allowed to elapse between penetration of a a sterile drug product container or after a lyophilized drug product has been reconstituted, and before patient administration. Some facilities and providers are considering use of certain drugs, for which supplies may not be consistently available, beyond the labeled 'in-use times.' As a result, the FDA is providing extended 'in-use time' guidance to ensure necessary access to these drugs and at the same time minimize the likelihood of physicochemical degradation or microbial proliferation in these scenarios. Further information regarding the FDA's guidance for extended 'in-use time' can be found at the following link: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/information-health-care-facilities-and-providers-use-time-covid-19.

FDA Guidance

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The US FDA is working with US Government partners, including Centers for Disease Control and Prevention (CDC), and international partners to address the COVID-19 outbreak. The FDA plays a critical role in protecting the US from threats including emerging infectious diseases. For continual updates and press releases, visit the following FDA website: https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19.

Last modified: 02/10/2021 12:40:44

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