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FDA authorizes Caption Guidance software with AI user guidance

The U.S. Food and Drug Administration (FDA) authorized marketing of software to assist medical professionals in the acquisition of cardiac ultrasound, or echocardiography, images. The software, called Caption Guidance, is an accessory to compatible diagnostic ultrasound systems and uses artificial intelligence (AI) to help the user capture images of a patient’s heart that are of acceptable diagnostic quality. “Today’s marketing authorization enables medical professionals who may not be experts in ultrasonography, such as a registered nurse in a family care clinic or others, to use this tool,” said Robert Ochs, Ph.D., deputy director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “This is especially important because it demonstrates the potential for artificial intelligence and machine learning technologies to increase access to safe and effective cardiac diagnostics that can be life-saving for patients.” More information on the FDA website.

Ervedo: First FDA-approved vaccine for Ebola prevention 

The U.S. Food and Drug Administration (FDA) announced the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older. The Democratic Republic of the Congo (DRC) is currently experiencing the world’s second largest EVD outbreak. “Ebola virus disease is a rare but severe and often deadly disease that knows no borders. Vaccination is essential to help prevent outbreaks and to stop the Ebola virus from spreading when outbreaks do occur,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. Detailed information on the approval can be found on the FDA website.

Wound care: EWMA & SFFPC join forces

The annual conference EWMA, from the European Wound Management Association, will have a new partner for the 2021 edition: As announced by the EWMA, the event - the largest of the specialty in Europe - will be in cooperation with the French Wound Healing Society (SFFPC). More information on the joint EWMA & Journées Cicatrisations Conference can be found on the EWMA website.