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2 天
GlobalData on MSNFDA grants 510(k) clearance for Tempus AI’s ejection fraction softwareThe US Food and Drug Administration (FDA) has granted 510(k) clearance for Tempus AI’s ECG-Low (ejection fraction) EF ...
Following priority review, the U.S. Food and Drug Administration approved Bayer's Kerendia (finerenone) for the treatment of ...
Patients taking Kerendia saw significant reduction in cardiovascular death and hospitalization and urgent visits for heart ...
Approval of Kerendia was based on results from the Phase III FINEARTS-HF trial, which demonstrated statistically significant ...
2 天
HealthDay on MSNKerendia Approved for Heart Failure With Left Ventricular Ejection Fraction ≥40%Following priority review, the FDA approved Kerendia for the treatment of patients with heart failure with left ventricular ejection fraction (LVEF) ≥40%.
Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care ...
The new Tempus software analyzes resting, non-ambulatory 12-lead ECG recordings to detect signs associated with having a low ...
4 天
MedPage Today on MSNFinerenone Gets Expanded FDA Approval in Heart FailureThe FDA expanded the indication for finerenone (Kerendia) in heart failure (HF), drug manufacturer Bayer announced.
Tempus AI Inc (NASDAQ:TEM) shares are trading higher Wednesday after the company announced that it received 510(k) clearance ...
US FDA approves Bayer’s finerenone for new indication in patients with heart failure with left ventricular ejection fraction of ≥ 40%: Berlin Wednesday, July 16, 2025, 13:00 H ...
The drug is now approved for treating people with an LVEF of at least 40%, with or without chronic kidney disease.
The FDA has approved Kerendia® (finerenone) to reduce the risk of cardiovascular death, hospitalization for HF, and urgent HF visits.
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