| This Week’s News | The agency warned that any unused devices should be removed from the market and returned to the manufacturer. The agency warned that any unused devices should be removed from the market and returned to the manufacturer. | | |
| Etripamil's journey toward FDA approval hit a roadblock. The agency requested additional information on the drug, including a new facility inspection, in a response letter sent to Milestone Pharmaceuticals. Etripamil's journey toward FDA approval hit a roadblock. The agency requested additional information on the drug, including a new facility inspection, in a response letter sent to Milestone Pharmaceuticals. | | |
| Aortic valve replacement is likely inevitable for patients with asymptomatic severe aortic stenosis. Immediately performing TAVR or SAVR, however, may not always be the answer. Aortic valve replacement is likely inevitable for patients with asymptomatic severe aortic stenosis. Immediately performing TAVR or SAVR, however, may not always be the answer. | | |
| GE HealthCare designed the new-look Revolution Vibe CT scanner to help hospitals and health systems embrace CCTA and improve overall efficiency. GE HealthCare designed the new-look Revolution Vibe CT scanner to help hospitals and health systems embrace CCTA and improve overall efficiency. | | |
| Michael J. Reardon, MD, shared the highly anticipated data with a large audience at ACC.25 in Chicago. Overall, he said, these five-year findings suggest TAVR with a supra-annular, self-expanding valve is a safe and effective alternative to SAVR. Michael J. Reardon, MD, shared the highly anticipated data with a large audience at ACC.25 in Chicago. Overall, he said, these five-year findings suggest TAVR with a supra-annular, self-expanding valve is a safe and effective alternative to SAVR. | | |
| Former American College of Cardiology president Hadley Wilson, MD, executive vice chair of Atrium Health Sanger Heart and Vascular Institute, explains his main takeaway messages from the ACC 2025 late-breaking trials. Former American College of Cardiology president Hadley Wilson, MD, executive vice chair of Atrium Health Sanger Heart and Vascular Institute, explains his main takeaway messages from the ACC 2025 late-breaking trials. | | |
| Patients who present with type 2 diabetes and PAD often face substantial mobility issues. According to new data presented at ACC.25, however, treatment with semaglutide could represent a major step forward for this high-risk population. Patients who present with type 2 diabetes and PAD often face substantial mobility issues. According to new data presented at ACC.25, however, treatment with semaglutide could represent a major step forward for this high-risk population. | | |
| Researchers focused on data from nearly 78,000 adults with cardiometabolic disorders, sharing their findings at ACC.25 in Chicago. Researchers focused on data from nearly 78,000 adults with cardiometabolic disorders, sharing their findings at ACC.25 in Chicago. | | |
| Researchers still think patients should receive an injectable version of semaglutide when possible, but new data out of ACC.25 confirm that an oral formulation of the drug is associated with significant benefits. Researchers still think patients should receive an injectable version of semaglutide when possible, but new data out of ACC.25 confirm that an oral formulation of the drug is associated with significant benefits. | | |
| Researchers tracked patient outcomes through the use of 15 performance measures related to hypertension, coronary artery disease, heart failure and atrial fibrillation. Researchers tracked patient outcomes through the use of 15 performance measures related to hypertension, coronary artery disease, heart failure and atrial fibrillation. | | |
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![A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]](https://cardiovascularbusiness.com/sites/default/files/styles/media_thumbnail/public/2024-09/istock-1209664264.jpg?itok=d9hdApI9)
