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Three Heart Surgeons Discuss How to Beat Aortic Dissection’s Ticking Clock

Participating in this Q&A article are Bilal Shafi, MD, from Sutter Health in Santa Cruz, California; Wilson Szeto, MD, from Penn Presbyterian Medical Center in Philadelphia, Pennsylvania; and Grayson H. Wheatley III, MD, Wheatley Surgical in Nashville, Tennessee.

The Joint Commission, Joint Commission Resources Launch Data Transparency Initiative

The Joint Commission and Joint Commission Resources (JCR) Inc. have announced a new data transparency initiative – Data Analytics for Safe Healthcare (DASH).

Aerobiotix Announces FDA 510(k) Clearance of Medical Ultraviolet Air Filtration System

Aerobiotix Inc., a manufacturer of air treatment devices for hospitals and health care, has announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Aerocure-MD medical air purification system.

AAAHC Releases Updated Toolkit Outlining Ambulatory Procedure Considerations for Obese Patients

To help ASCs implement necessary precautions and prevent negative outcomes for obese patients, the Accreditation Association for Ambulatory Health Care (AAAHC) has published a fully revised Ambulatory Procedure Considerations for Obese Patients Toolkit.

FDA Issues COVID-19 Update

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • In a new FDA Voices, titled FDA maintains the pace of meeting its goals on applications for medical products during the pandemic, FDA Commissioner Stephen M. Hahn, M.D., explains that one of the challenges facing the FDA during the COVID-19 pandemic is how to ensure the timely reviews of medical product applications despite a surge in volume of work and practical constraints that may impact our ability to conduct on-site inspections. The FDA has maintained the same pace of meeting its goals on review of applications for medical products during the pandemic that it has maintained in recent years.
  • The FDA is partnering with the Critical Path Institute (C-Path) and the National Institutes of Health’s National Center for Advancing Translational Sciences (NCATS) on the CURE Drug Repurposing Collaboratory (CDRC). CDRC is a forum for the exchange of clinical practice data to inform potential new uses of existing drugs for areas of high unmet medical need, advancing research in these areas. CDRC will focus on capturing relevant real-world clinical outcome data through the FDA-NCATS CURE ID platform. In a pilot project focused on COVID-19, CDRC will use data collected via the CURE ID platform to aggregate global clinician treatment experiences to identify existing drugs that demonstrate possible treatment approaches warranting further study.
  • A Consumer Update, titled Getting Smarter about Food Safety: The Pandemic and Lessons Learned, explains that throughout the COVID-19 pandemic, the experts at the FDA have learned valuable lessons that will help shape our work to create a more digital and transparent, as well as safer, food system for you and your family. In the coming weeks, the FDA will unveil the blueprint for the New Era of Smarter Food Safety, which lays out how we will use technology and modern approaches over the next decade to strengthen the ways we approach the safety of the nation’s food supply, every day and in times of crisis.
  • Testing updates:
    • To date, the FDA has authorized 145 tests under EUAs; these include 122 molecular tests, 22 antibody tests, and 1 antigen test.

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