Patients impacted by this recall are advised to speak with a physician about how to proceed. 

The FDA has been busy this month. Review some of the biggest FDA-related stories of October, including big news from scPharmaceuticals, Abiomed, Bristol Myers Squibb and MedAlliance, in our monthly roundup. 

Ed Nicol, MD, president-elect of the Society of Cardiovascular Computed Tomography, provided us with an exclusive look at how AI is expected to change cardiac imaging.

BASILICA was considered for the 67-year-old female patient, but UNICORN was seen as an overall better option. The full case study was published in Circulation: Cardiovascular Interventions.

“Once the study begins, it will likely be one of the largest heart pacing clinical trials happening in the world over the next few years," one specialist said. 

Vaccine-related myocarditis was seen in approximately 0.00005% of children between the ages of 12 and 15. All cases were mild, and the median length of stay at the hospital was three days. 

“The findings of this study are important because they provide fresh evidence that the use of e-cigarettes could interfere with normal heart rhythms—something we did not know before,” according to one specialist. 

Researchers tracked outcomes data and imaging results from nearly 4,000 TEER patients, sharing their findings in the Journal of the American College of Cardiology.