All 15 members of the FDA's Circulatory System Devices Panel agreed that more data is required to confirm the new device from Johnson & Johnson MedTech is effective. Will the agency agree with these recommendations? Only time will tell. All 15 members of the FDA's Circulatory System Devices Panel agreed that more data is required to confirm the new device from Johnson & Johnson MedTech is effective. Will the agency agree with these recommendations? Only time will tell. | | |
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The Hotwire Transseptal Access System includes the Hotwire RF Generator and Hotwire RF Guidewire, giving electrophysiologists the tools they need for left-heart access. The Hotwire Transseptal Access System includes the Hotwire RF Generator and Hotwire RF Guidewire, giving electrophysiologists the tools they need for left-heart access. | | |
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Two of the world's leading healthcare companies have partnered on a new treatment option for patients with type 1 diabetes. Two of the world's leading healthcare companies have partnered on a new treatment option for patients with type 1 diabetes. | | |
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The sensor-guided device delivers continuous hemodynamic measurements and rapid left ventricular pacing during TAVR procedures. Back in 2023, it was at the heart of a $253 million acquisition. The sensor-guided device delivers continuous hemodynamic measurements and rapid left ventricular pacing during TAVR procedures. Back in 2023, it was at the heart of a $253 million acquisition. | | |
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There is a risk of certain pericardial patches not being as strong or durable as needed. Customers are urged to identify, quarantine and replace these devices. There is a risk of certain pericardial patches not being as strong or durable as needed. Customers are urged to identify, quarantine and replace these devices. | | |
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SCAI and CRT have announced a new partnership focused on education, advocacy and research. SCAI and CRT have announced a new partnership focused on education, advocacy and research. | | |
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Hemostemix believes its new cell therapy platform can help treat peripheral artery disease, congestive heart failure, cardiomyopathy and other serious medical conditions. The company plans on scooping up multiple practices to conduct additional research and increase the use of its platform. Hemostemix believes its new cell therapy platform can help treat peripheral artery disease, congestive heart failure, cardiomyopathy and other serious medical conditions. The company plans on scooping up multiple practices to conduct additional research and increase the use of its platform. | | |
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The cloud-enabled system provides the foundation for future AI-enabled tools, better workflows and analytics. The cloud-enabled system provides the foundation for future AI-enabled tools, better workflows and analytics. | | |
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SCAI feels this is the best way forward to try lowering mortality rates, but the group is asking cardiologists to help by gathering more data. SCAI feels this is the best way forward to try lowering mortality rates, but the group is asking cardiologists to help by gathering more data. | | |
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The agreement also will make Boston Scientific the exclusive distributor for the new ICE catheter optimized for left atrial appendage occlusion workflows. The agreement also will make Boston Scientific the exclusive distributor for the new ICE catheter optimized for left atrial appendage occlusion workflows. | | |
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HHS’s 340B drug discount program is set to shift to a rebate model on New Year’s Day. But a lawsuit and temporary restraining order filed by the AHA and others may block the change from going live on time. HHS’s 340B drug discount program is set to shift to a rebate model on New Year’s Day. But a lawsuit and temporary restraining order filed by the AHA and others may block the change from going live on time. | | |
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Artera, a company that utilizes AI for patient communications, made the announcement while revealing it has achieved $100 million in annual revenue. Its products use AI for follow-ups after patient care, in addition to supporting clinical decisions. Artera, a company that utilizes AI for patient communications, made the announcement while revealing it has achieved $100 million in annual revenue. Its products use AI for follow-ups after patient care, in addition to supporting clinical decisions. | | |
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