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Recall | Product recall

Cardiovascular devices are more likely to be in a Class I recall than any other device type. The FDA's approval process appears to be at least partially responsible, though the agency is working to make some serious changes. We spoke to a researcher who has been tracking these data for years to learn more. 

child in shock from noise trauma

The Michigan Department of Health and Human Services failed to notify staff and law enforcement that a simulation at the state-run facility was taking place, resulting in chaos. 

DOJ U.S. Department of Justice HQ

Federal Data Solutions allegedly failed to encrypt screenshots of patient data, stored on a server being paid for with Medicare funds.

Heartflow Roadmap AI can show the locations and severity of coronary lesions from a CT scan to act as a second set of eyes for imagers, and to better inform referring physicians and patients.

The California-based company, fresh off receiving expanded Medicare coverage and a new Category I CPT code for its AI offerings, will have a significant presence at TCT 2024. 

In a letter, the undersigned asked Congress to halt cuts to Medicare reimbursement and enact a permanent system to adjust rates to inflation. 

During the 2022 State of the Union address, President Biden outlined a new plan to combat COVID-19 by testing and immediate treatment, plans to reduce drug costs, the need for more mental health coverage, and a call for more cancer research under an NIH program.

The Biden Administration has invoked parts of the Defense Production Act to address shortages that stem from Hurricane Helene damaging a Baxter production facility in North Carolina. 

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More than 33,000 devices are affected by this recall. Customers may need to return and replace the purge cassettes included with their devices due to a risk of serious injury or death.