The US Food and Drug Administration awarded Impedimed’s Sozo device the title of breakthrough device for the treatment of renal failure. The company’s bioimpedance spectroscopy device uses a gentle current to measure the user’s body composition. In this case, it will be used to more accurately measure how much fluid should be removed during dialysis.
The current standard of care only measures the weight change between appointments. But this is a rough tool and may miss other causes of weight fluctuations. For example, some patients with chronic kidney disease experience protein energy consumption, they are losing muscle mass but retaining fluid. Removing too much or too little fluid is not good for the patient.
Impedimed CEO Rick Carreon said in an interview: “They are looking for a fast, highly accurate, and reliable way to understand how much fluid needs to be removed from the patient for each treatment.”…A more precise way can be. Extend life and improve outcomes, and benefit patients over time,” he said.
The FDA’s breakthrough device designation is dedicated to devices that can provide more effective treatments for life-threatening or debilitating diseases. This will allow Impedimed to work closely with the agency to speed up the review process.
Carreon said the company has been planning to seek breakthrough designations for some time. Its equipment has received the CE mark in Europe for the management of patients with renal failure.
Impedimed has also received four other FDA approvals, including the use of its equipment Detect lymphedema in cancer patients.
In the future, Carreon stated that he hopes to see the tool expand from clinical assessment to a broader digital health platform, bringing this information into the electronic health records of dialysis clinics. For example, they can compare the performance of one clinic with the performance of another clinic to see if they get better results or if they need more services, such as nutrition counseling.
“If you can see a more successful clinic and learn from them, that’s where we see population health and dialysis really start to compound,” he said.
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