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Home » No sweat: Aquapass Microclimate Suit enters FDA pre-submission application stage
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No sweat: Aquapass Microclimate Suit enters FDA pre-submission application stage

March 8, 2023
By David Godkin
No Comments
Aquapass Medical Ltd. has readied a pre-submission plan for the FDA this month to advance technology designed to reduce hypervolemia or fluid overload in patients suffering from heart failure, kidney failure or lymphedema. Conjuring up images of an astronaut stepping out onto a NASA loading dock, the Microclimate Suit uses low humidity and fast flowing air on the patient’s skin to evaporate excess bodily fluids. The suit won FDA breakthrough device designation in December 2022.
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