FDA names the first five companies in its READI-Home readmissions program

CDRH named its first five READI-Home participants on October 1: BD, Epitel, Prapela, Current Health and Skribe Medical. READI-Home stands for Reducing Readmissions through Device Innovation for the Home, and it sits under the Home as a Healthcare Hub program CDRH started in 2024.

The devices have little in common. BD brought a capillary blood self-collection kit for adults. Epitel entered its wireless wearable EEG for patients 6 and older being worked up for seizures, sleep problems or delirium. Prapela submitted a crib mattress pad that vibrates for infants with single-ventricle heart disease. Current Health offered software that scores CAR-T patients for cytokine release syndrome risk. Skribe Medical brought a wearable patch that estimates left ventricular ejection fraction.

Participants get early engagement with FDA, feedback on device design and testing, and demonstrations at the agency's research facilities. FDA plans to select nine companies in total by December 4.

Three of the five are small companies, which is the point of running a challenge rather than a guidance. Design feedback before a submission costs a lot less than a refuse-to-accept letter after one.