The new warnings, first proposed to Pfizer and Moderna in April, are now officially required by the FDA. They provide additional information about the potential risks of myocarditis and/or pericarditis associated with these vaccines. The new warnings, first proposed to Pfizer and Moderna in April, are now officially required by the FDA. They provide additional information about the potential risks of myocarditis and/or pericarditis associated with these vaccines. | | |
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The Aventus Thrombectomy System was already cleared to treat blood clots in the peripheral arteries. This latest approval comes after positive results from an IDE study were published in JSCAI. The Aventus Thrombectomy System was already cleared to treat blood clots in the peripheral arteries. This latest approval comes after positive results from an IDE study were published in JSCAI. | | |
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CMS has finalized a new national coverage determination for T-TEER, sometimes known as transcatheter tricuspid valve repair. Abbott's TriClip is the only device approved by the FDA for T-TEER, but other treatment options are under development. CMS has finalized a new national coverage determination for T-TEER, sometimes known as transcatheter tricuspid valve repair. Abbott's TriClip is the only device approved by the FDA for T-TEER, but other treatment options are under development. | | |
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American College of Cardiology Board of Governors Chair David E. Winchester, MD, MS, examines the many benefits of working with the American Medical Association House of Delegates to bring about significant change. American College of Cardiology Board of Governors Chair David E. Winchester, MD, MS, examines the many benefits of working with the American Medical Association House of Delegates to bring about significant change. | | |
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The cuffless technology, which has already gained CE mark approval, should make its U.S. debut in 2026. The cuffless technology, which has already gained CE mark approval, should make its U.S. debut in 2026. | | |
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All over the United States, countless research projects designed to improve outcomes have lost funding or been shut down. Even screening efforts targeting patients in impoverished communities have been impacted by these policies. All over the United States, countless research projects designed to improve outcomes have lost funding or been shut down. Even screening efforts targeting patients in impoverished communities have been impacted by these policies. | | |
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The FDA's 2024 approval of the Farapulse system covered patients with paroxysmal atrial fibrillation. Now, however, the technology is officially approved for patients with more persistent symptoms. The FDA's 2024 approval of the Farapulse system covered patients with paroxysmal atrial fibrillation. Now, however, the technology is officially approved for patients with more persistent symptoms. | | |
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The Heart Rhythm Society and its new advocacy arm plan on pushing CMS to include certain policy improvements in the 2026 MPFS. The Heart Rhythm Society and its new advocacy arm plan on pushing CMS to include certain policy improvements in the 2026 MPFS. | | |
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After their proposal for a new American Board of Cardiovascular Medicine was shot down earlier this year, cardiology groups have asked the AMA for some support. "We feel like it's time for us to blaze our own path," one specialist explained. After their proposal for a new American Board of Cardiovascular Medicine was shot down earlier this year, cardiology groups have asked the AMA for some support. "We feel like it's time for us to blaze our own path," one specialist explained. | | |
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Staying vaccinated as recommended by doctors can help patients limit their risk of adverse cardiovascular events, according to a new consensus statement published in European Heart Journal. Staying vaccinated as recommended by doctors can help patients limit their risk of adverse cardiovascular events, according to a new consensus statement published in European Heart Journal. | | |
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The group highlighted the proven effectiveness of these drugs, especially semaglutide and tirzepatide, while noting that eligibility, affordability and availability will still play key roles in any treatment decisions. The group highlighted the proven effectiveness of these drugs, especially semaglutide and tirzepatide, while noting that eligibility, affordability and availability will still play key roles in any treatment decisions. | | |
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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)
