The FDA has named five initial participants in its READI-Home challenge to accelerate home-based devices that could reduce hospital readmissions. The cohort—BD, Epitel, Prapela, Current Health and Skribe Medical—offers technologies ranging from home blood-collection kits and wearable EEGs to a vibrating crib mattress, AI monitoring for CAR-T patients and a cardiac-function patch. The agency will select nine participants by Dec. 4 and will provide early design and testing feedback as part of the Home as a Healthcare Hub initiative launched in 2024.
FDA Taps Five Innovators for READI-Home Challenge to Cut Hospital Readmissions
A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
The U.S. Food and Drug Administration has selected the first five participants in its READI-Home innovation challenge, a program aimed at accelerating development of home-use devices and technologies that could help reduce hospital readmissions.
READI-Home (Reducing Readmissions through Device Innovation for the Home) is run by the FDA's Center for Devices and Radiological Health (CDRH). The agency will expand the cohort to a total of nine participants by Dec. 4, 2024. Selected teams will receive opportunities for early engagement with the FDA, including design and testing feedback and the chance to demonstrate technologies at FDA research facilities.
The first five participants are:
BD — Entering with a home self-collection blood sampling kit that enables adults to collect capillary blood at home for later laboratory testing.
Epitel — A wearable EEG company offering a wireless system intended for use after hospital discharge in patients aged 6 and older who are being evaluated for seizures, disrupted sleep or delirium.
Prapela — Produces a crib mattress that delivers gentle, randomized vibrations while an infant sleeps to reduce the frequency, duration and severity of hypoxemic and bradycardic episodes in babies with single-ventricle heart disease. The device is intended for use during the high-risk interstage period between surgeries.
Current Health — Developer of AI-enabled software to help clinicians identify and monitor complications in cancer patients receiving chimeric antigen receptor T-cell (CAR-T) therapy. The platform aims to support remote monitoring for serious reactions such as cytokine release syndrome.
Skribe Medical — Created a wearable patch designed for home or caregiver use that estimates left ventricular ejection fraction, a key measure of heart-pumping function; measurements are transmitted to clinicians for interpretation.
The READI-Home challenge is part of the FDA's broader Home as a Healthcare Hub initiative, launched in 2024 by CDRH Director Michelle Tarver. The initiative encourages device developers to factor patients' lived environments into design and testing with the goal of improving access, safety and health equity in home-based care.
By providing early regulatory feedback and demonstration opportunities, the FDA hopes to speed safe, effective solutions that keep patients healthier at home and reduce preventable readmissions.
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