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U.S. Centers for Disease Control and Prevention

CDC urges universal mask use when not at home

December 4, 2020 By Nancy Crotti

With the pandemic death toll reaching new heights every day, the U.S. Centers for Disease Control and Prevention issued a blanket recommendation for the nation on Friday: Every American should wear a face mask when not at home. And when they are at home with someone who is infected or has had recent potential COVID-19 […]

Filed Under: Regulatory/Compliance, Respiratory Tagged With: coronavirus, COVID-19, U.S. Centers for Disease Control and Prevention

FDA allows dry heat treatment for single-user mask reuse

November 30, 2020 By Nancy Crotti

The FDA has announced that it will allow the use of dry heat to lower the bioburden on masks used by healthcare workers treating COVID-19 patients. While not authorizing equipment made by a particular company, guidance released last week said healthcare providers may use dry heat to reprocess NIOSH-approved filtering facepiece respirators, such as N95s, […]

Filed Under: Featured, Food & Drug Administration (FDA), Hospital Care, Lab Instruments & Supplies, Regulatory/Compliance Tagged With: coronavirus, COVID-19, FDA, National Institute for Occupational Safety and Health, U.S. Centers for Disease Control and Prevention

Who would — and wouldn’t — line up for COVID-19 vaccines?

November 24, 2020 By Nancy Crotti

Once enough people receive effective vaccines against the novel coronavirus, experts say, the end of the pandemic may be in sight. But a new poll of older adults — one of the highest-priority groups for vaccination — suggests an uphill climb lies ahead to reach that goal. In all, 58% of adults aged 50 to […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceutical, Research & Development Tagged With: AARP, BioNTech, coronavirus, COVID-19, Moderna, Pfizer, U.S. Centers for Disease Control and Prevention, UBS, University of Michigan, vaccines

CDC: Ethylene oxide may have more health effects than cancer

October 1, 2020 By Nancy Crotti

The Centers for Disease Control and Prevention yesterday released a draft toxicity profile of ethylene oxide (EtO) that treats it as a more far-reaching health threat than the Environmental Protection Agency does. The EPA and the federal Department of Health and Human Services both consider EtO a human carcinogen. The medical device industry relies on […]

Filed Under: Featured, Sterilization / Calibration Tagged With: ethylene oxide, U.S. Centers for Disease Control and Prevention, U.S. Environmental Protection Agency

U.S. should have enough COVID-19 vaccine by Q3 2021, CDC head tells Senate panel

September 16, 2020 By Nancy Crotti

CDC director Dr. Robert Redfield told a Senate panel today that the federal government should have enough coronavirus vaccine for Americans to resume “regular life” by the third quarter of 2021, according to a report by CNBC. Redfield said vaccinations could begin November or December of 2020 and that it could take 6 to 9 months to […]

Filed Under: Distribution, Drug-Device Combinations, Featured Tagged With: coronavirus, COVID-19, U.S. Centers for Disease Control and Prevention, U.S. Senate, vaccines

Feds unveil COVID-19 vaccine distribution plan

September 16, 2020 By Nancy Crotti

The Trump administration today released a plan to distribute an eventual COVID-19 vaccine free of charge, initially to targeted groups and more broadly as supply increases. The government is planning a phased distribution using a contract awarded to McKesson in August. The first recipients could include: Healthcare personnel likely to be exposed to or treat […]

Filed Under: Business/Financial News, Distribution, Drug-Device Combinations, Featured, Lab Instruments & Supplies, Pharmaceutical Tagged With: becton dickinson, coronavirus, COVID-19, McKesson, U.S. Centers for Disease Control and Prevention, U.S. Department of Defense, U.S. Department of Health and Human Services

Report: Will Dr. Hahn crack under political pressure?

August 10, 2020 By Nancy Crotti

Many jobs have come with increased stress levels during the coronavirus pandemic, from ICU staff to Walmart greeters. Now officials who’ve been keeping tabs on FDA commissioner Dr. Stephen Hahn are wondering whether he can weather the strain of defending science while working for the Trump administration, according to a New York Times report. Hahn […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: coronavirus, COVID-19, Donald Trump, FDA, U.S. Centers for Disease Control and Prevention, U.S. Department of Health and Human Services

Abbott: ID NOW COVID-19 results more accurate with earlier testing

May 21, 2020 By Nancy Crotti

Abbott (NYSE:ABT) said today that its ID NOW COVID-19 test works better on specimens collected soon after patients begin showing symptoms. The test’s performance has drawn fire from federal officials in recent weeks, including a recent FDA warning that the ID NOW test may return false-negative results. The agency granted the test an emergency use authorization […]

Filed Under: Business/Financial News, Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Research & Development, Wall Street Beat Tagged With: Abbott, coronavirus, COVID-19, Everett Clinic, FDA, Johns Hopkins, Roche, U.S. Centers for Disease Control and Prevention

Groups release guidance on medtech reps’ return to hospitals

May 19, 2020 By Nancy Crotti

A handful of medical organizations released guidelines today on the safe return of medtech company representatives to healthcare facilities during the coronavirus pandemic. The guidance released today by AdvaMed, the Association of periOperative Registered Nurses (AORN) and the American Hospital Association (AHA) builds on the April 17 joint statement by AHA, AORN, the American College […]

Filed Under: Business/Financial News, Featured, Hospital Care, Surgical Tagged With: AdvaMed, American College of Surgeons, American Hospital Assn., American Society of Aesthesiologists, Association of periOperative Registered Nurses, coronavirus, COVID-19, FDA, U.S. Centers for Disease Control and Prevention

3M, Ford to begin shipping respirators to COVID-19 first responders

May 6, 2020 By Nancy Crotti

3M (NYSE:MMM) and Ford Motor Company announced today that they have begun shipping 10,000 of the jointly developed powered air-purifying respirators (PAPRs) to healthcare workers fighting COVID-19. Production began April 13 at Ford’s Vreeland facility near Flat Rock, Mich., after 40 days of development, according to 3M. 3M said it will sell and distribute the PAPRs […]

Filed Under: Business/Financial News, Distribution, Featured, Hospital Care, Respiratory Tagged With: 3m, coronavirus, COVID-19, Ford Motor Company, U.S. Centers for Disease Control and Prevention

AdvaMed’s Whitaker calls for pandemic cooperation

May 6, 2020 By Tom Salemi

Preparation for future pandemics will require closer cooperation between the medtech industry and the U.S. government, according to Scott Whitaker, CEO and president of the trade group AdvaMed. In an interview on the DeviceTalks Weekly podcast, Whitaker laid out steps he believes the federal government and medtech industry must take, including addressing medical device and […]

Filed Under: Business/Financial News, Device Talks Podcasts, Diagnostics, Distribution, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: AdvaMed, coronavirus, COVID-19, U.S. Centers for Disease Control and Prevention, U.S. Department of Health and Human Services

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