- ImpediMed Limited (ASX:IPD) has received the FDA 510(k) clearance for its SOZO® device to include a heart failure index (HF-DexTM).
- HF-DexTM provides medically meaningful and actionable data, enabling clinicians to manage heart failure patients more effectively and efficiently.
- The FDA 510(k) clearance is a major step in SOZO® becoming the standard of care for the management of heart failure patients, says MD & CEO Richard Carreon.
The stock of medical technology company ImpediMed Limited (ASX:IPD) traded up by a significant 8.69% at A$0.125 on 22 April 2021. The trading volume was a whopping 2.62 million and the Company’s market capitalisation stood at A$171.54 million.
Investors seem to have responded positively to the bioimpedance spectroscopy (BIS) technology pioneer after it announced the receipt of the United States Food and Drug Administration 510(k) clearance to include HF-DexTM in its SOZO® device. This would be a monitoring tool for patients living with heart failure.
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What is SOZO® HF-DexTM?
SOZO® HF-Dex presents a measure of fluid levels to help in the clinical assessment of heart failure patients. The analysis is attained via a simple, non-invasive, easy to administer, 30-second test. HF-Dex is presented along with the normal fluid volume reference ranges and results are displayed graphically (to enable tracking over time).
Reference ranges are provided from grey to dark blue to help visualise the surges in extracellular fluid relative to a typical healthy population.
Graphic results of HF-Dex analysis (Source: Company’s announcement, 22 April 2021)
Key advantages of HF-Dex are-
- When used in conjunction with other clinical data, HF-Dex can help clinicians to risk stratify heart failure patients with fluid management problems.
- It provides medically meaningful and actionable data, enabling clinicians to manage heart failure patients more effectively and efficiently.
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Richard Carreon, Managing Director and CEO of the Company, believes that the expanded clearance for the inclusion of a heart failure index is a key step in SOZO® becoming the standard of care for heart failure patients.
He further states that the use of HF- Dex will offer clinicians with unparalleled insights. They will be better placed to understand the extracellular fluid accumulation in heart failure patients. Notably, this has not otherwise been readily available to them before.