Cardiosense’s CardioTag Device Receives the US FDA’s 510(k) Clearance for Cardiac Function Assessment

Shots: The US FDA has granted 510(k) clearance to CardioTag device for assessing cardiac function Upon regulatory approval for the PCWP Analysis Software, the algorithm will be integrated with the CardioTag device for advanced heart failure management, following a multicenter study showing its PCWP value estimates matched implantable hemodynamic sensor accuracy in HFrEF pts; data was published…

ByRidhi RastogiJuly 31, 2025

NEWS

Bayer Reports the US FDA’s Approval of Kerendia (Finerenone) to Treat Heart Failure (HF)

Shots: The US FDA has approved Kerendia/Firialta (10, 20, & 40mg) for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Awaits authorization in China, EU & Japan, with global applications planned Approval was based on the P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n=15000) study, where…

ByRidhi RastogiJuly 14, 2025

NEWS

Bayer Reports the US FDA’s sNDA Acceptance & Priority Review of Finerenone for Heart Failure (HF)

Shots: The US FDA has accepted sNDA & granted priority review to finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF), with approval expected in Q3’25. Awaits authorization in China, EU & Japan, with global applications planned Application was backed by P-III…

ByRidhi RastogiMarch 18, 2025

NEWS

Bayer Submits MAA of Finerenone to Japan’s MHLW for Heart Failure (HF)

Shots: Japan’s MHLW received MAA of finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Regulatory review is ongoing in the US, EU & China, with global filings planned Application was backed by P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n>15000)…

ByRidhi RastogiFebruary 14, 2025

NEWS

Bayer Submits MAA of Finerenone to the EMA for Heart Failure (HF)

Shots: The EMA received MAA of finerenone for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Awaits approval in US and China, with global applications planned Application was backed by P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n=15000) study, where FINEARTS-HF assessed…

ByDipanshu DixitFebruary 4, 2025

VIEWPOINTS

Ruud Dobber Shares Insights from RWE Data from the REVEAL-CKD Presented at the ERA-EDTA’23

Shots: Ruud talked about the key findings from the new RWE data at ERA-EDTA'23 which demonstrated the staggeringly low rate of diagnosis in chronic kidney disease (CKD) He then discussed the risk factors of CKD and the urgent need to act on the growing global burden of CKD and how this disease is impacting the…

BySenior EditorSeptember 25, 2023

EXCLUSIVE

Johanna Contreras and Lupe Share Insights from the Cuide Su Corazón Campaign

Shots: Johanna Contreras, Director of the Ambulatory Heart Failure Network & Diversity Mount Sinai Health System spoke about the initiation of this campaign and how it is empowering Latina women with heart failure to prioritize their heart health Lupe, a woman diagnosed with heart failure, shared her experience of her life with heart failure and…

BySenior EditorJanuary 30, 2023

Cardiosense’s CardioTag Device Receives the US FDA’s 510(k) Clearance for Cardiac Function Assessment

Bayer Reports the US FDA’s Approval of Kerendia (Finerenone) to Treat Heart Failure (HF)

Bayer Reports the US FDA’s sNDA Acceptance & Priority Review of Finerenone for Heart Failure (HF)

Bayer Submits MAA of Finerenone to Japan’s MHLW for Heart Failure (HF)

Bayer Submits MAA of Finerenone to the EMA for Heart Failure (HF)

Ruud Dobber Shares Insights from RWE Data from the REVEAL-CKD Presented at the ERA-EDTA’23

Johanna Contreras and Lupe Share Insights from the Cuide Su Corazón Campaign

Contact US

OUR INFORMATION

FOLLOW US