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News

FDA updates EUAs for COVID-19 antigen tests, alerts providers to device recall and shortage

The FDA revised its emergency use authorizations for all COVID-19 antigen tests to authorize serial testing and require updates to product labeling regarding serial testing, and designated the recall of 60,500 filters used in breathing systems a Class I recall.
News

FDA issues update on heart device recall

All hospitals may request a backup controller with modified software for the Heartware Ventricular Assist Device System to use in certain circumstances if the primary controller fails to restart the pump, the Food and Drug Administration announced today.
News

FBI recommends action to protect vulnerable medical devices from cyberattacks

The FBI today released recommendations to help protect medical devices from cyberattacks that can threaten health care operations, patient safety, and data privacy and integrity, citing a growing number of unpatched medical device vulnerabilities.
News

AHA presses Bureau of Land Management to work with HHS, others to secure helium pipeline

The AHA last week encouraged the Bureau of Land Management to work with the Health and Human Services Assistant Secretary for Preparedness and Response, the Centers for Medicare & Medicaid Services, and the Food and Drug Administration to assist in taking steps to protect access to helium prior to executing the final sale of the Federal Helium Reserve near Amarillo, Texas.
News

FDA issues update on Medtronic’s HeartWare Ventricular Assist Device system

The Food and Drug Administration yesterday provided an update on the HeartWare Ventricular Assist Device system.
AHA Center for Health Innovation Market Scan

5 Ways Apple Provider Partnerships Are Guiding Its Strategy

In a new report initiated by Chief Operating Officer Jeff Williams, Apple ties together its expansive devices and applications, its partnerships with hospitals and health systems and work with researchers.
AHA Center for Health Innovation Market Scan

CVS, Walgreens Take On Clinical Trials to Improve the Patient Experience

CVS Health and Walgreens recently launched clinical trials businesses with an eye toward reducing research costs and making it easier for historically underrepresented racial and ethnic groups to participate in drug and medical device studies.
News

House passes bill to reauthorize FDA user fee programs

The House voted to pass legislation that would reauthorize FDA user fee programs.
AHA Center for Health Innovation Market Scan

3 Things We Learned from the HIMSS Global Conference

The recent Healthcare Information and Management Systems Society (HIMSS) Global Conference gave tech firms, pharmacy retailers and provider organizations a chance to share insights about digital advances and how they may impact future health care delivery. Here’s what caught our attention during last week’s event.
Sponsored White Papers

Surgeon Satisfaction with Medical Device Choice

How Technological Advancements in Prosthetic Cardiac Valves Can Improve Healthcare Provider Satisfaction and Evolve Standard of Care.