Dive Brief:
- The Food and Drug Administration has selected the first participants for an innovation challenge for home devices that could be used to reduce hospital readmissions.
- The first five participants include large medtech firm BD, wearable EEG startup Epitel, infant care company Prapela, Current Health, a company making software for cancer care, and Skribe Medical, which makes a device to assess cardiac function.
- The FDA’s device center plans to choose a total of nine participants by Dec. 4 for the challenge, called Reducing Readmissions through Device Innovation for the Home, or READI-Home. The selected manufacturers will have opportunities for early engagement with the FDA, including feedback on device design and testing, and demonstrations at the agency’s research facilities.
Dive Insight:
The five participants address a variety of health needs. Epitel makes a wireless wearable EEG system used after a person is discharged from the hospital. The device is intended for people 6 years and older who are being assessed for seizures, poor sleep or delirium.
Prapela makes a crib mattress that provides gentle, randomized vibrations while an infant is sleeping to reduce the frequency, duration and severity of hypoxemic and bradycardic episodes in babies with single-ventricle heart disease. Prapela intends for the device to be used in between surgeries to treat the condition, which can be a high-risk period.
BD is entering the program with a home self-collection blood sampling kit for adults. It’s intended to allow adults to collect a capillary blood specimen at home for subsequent testing.
Current Health has developed artificial intelligence-enabled software to help healthcare professionals identify the risk for cancer patients undergoing chimeric antigen receptor T-cell, or CAR-T, therapy. One of the risks of CAR-T therapy is cytokine release syndrome, a serious immune reaction. Current’s solution would allow people undergoing the treatment to be monitored in a home setting.
Finally, Skribe Medical has developed a wearable patch that patients or caregivers can use at home to estimate a key measure of heart function, left ventricular ejection fraction, the amount of blood pumped out with each heartbeat. The results are sent to a healthcare professional for interpretation.
The READI-Home Innovation Challenge is part of the FDA’s Home as a Healthcare Hub initiative, which was launched by Center for Devices and Radiological Health Director Michelle Tarver in 2024 to consider people’s lived environments in device design with the goal of improving health equity.
