The Centers for Disease Control and Prevention Dec. 11 released a report that found last year’s version of the COVID-19 vaccine was 76% effective in preventing emergency department or urgent care visits for children ages 9 months to 4 years.
COVID-19: CDC, FDA and CMS Guidance
This page includes AHA Today stories and other AHA content on coronavirus COVID-19 guidance from the CDC, FDA, and CMS.
The AHA provided recommendations to the Food and Drug Administration Dec. 1 in response to a request for information on the measurement and evaluation of artificial intelligence-enabled medical devices.
The Food and Drug Administration has identified a Class I recall of Baxter Life2000 Ventilation Systems due to a cybersecurity issue discovered through internal testing. The devices are being permanently recalled and the FDA advised customers to stop using the product.
The Food and Drug Administration yesterday published an announcement from Otsuka ICU Medical saying that the company issued a voluntary recall for a mislabeled lot of 20 mEq potassium chloride injection bags. The notice said the products are incorrectly labeled with a 10 mEq overwrap.
The Centers for Disease Control and Prevention will update its immunization schedules for the COVID-19 and chickenpox vaccines to adopt recent recommendations by the Advisory Committee on Immunization Practices.
The Food and Drug Administration today issued a request for public comment on a series of questions regarding current approaches to evaluating artificial intelligence-enabled medical device performance in real-world applications. This includes approaches to detect, assess and mitigate performance…
The Food and Drug Administration yesterday announced that Olympus issued a global recall of its ViziShot 2 FLEX needles manufactured prior to May 12 following reports of device components detaching during procedures. The company was alerted to incidents resulting in one patient death and one injury…
The Food and Drug Administration has identified a Class I recall for Mo-Vis BVBA R-net Joysticks due to a firmware error that causes the wheelchair to ignore its neutral setting and allows it to move unexpectedly. The FDA said there has been one reported injury and no deaths related to the issue.…
COVID-19 infections are growing or likely growing in 45 states and not changing in five states, according to the latest data from the Centers for Disease Control and Prevention Aug. 8. Wastewater levels for COVID-19 have been classified as moderate nationwide, with the highest detected in the…
The Food and Drug Administration July 15 announced a recall by Sandoz on certain lots of cefazolin, due to the lots being mislabeled as penicillin G potassium. The FDA said the inadvertent administration of cefazolin following a recommended dosage of penicillin G potassium could pose serious and…