Shots:
- The FDA has granted De Novo classification to Cardiosense‘s PCWP Analysis Software to noninvasively estimate pulmonary capillary wedge pressure (PCWP) in adults with heart failure with reduced ejection fraction (HFrEF), incl. those with LVEF ≤40% & NYHA Class II, III & IV symptoms
- The Software integrates its CardioTag wearable sensor with AI to deliver non-invasive, highly precise PCWP estimates, allowing early detection of cardiac deterioration & therapy optimization before hospitalization is required
- The technology demonstrated accuracy comparable to implanted pressure sensors in findings published in the JACC: Heart Failure & presented at the AHA’24
Ref: Businesswire | Image: Cardiosense | Press Release
Related News: Cardiosense’s CardioTag Device Receives the US FDA’s 510(k) Clearance for Cardiac Function Assessment
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