Prapela has been selected by the FDA to advance to the interaction phase of the Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation Challenge with its Prapela® Therapeutic Vibrational Crib Mattress. The mattress delivers low-amplitude, broadband stochastic vibration during infant sleep to reduce the frequency, duration and severity of hypoxemic and bradycardic episodes in infants with single-ventricle heart disease during the interstage period between staged surgeries.
The goal of the READI-Home Innovation Challenge is to accelerate patient access to medical device technologies aimed at reducing hospital readmission. Participants selected to advance to the interaction phase receive early engagement with the FDA through “sprint” discussions, including more frequent interactions and feedback to help refine device design and/or relevant testing for home use indications.