FDA Picks First Five Home Devices for READI-Home Readmissions Challenge

The FDA has named the first five companies selected for its READI-Home Innovation Challenge, a program meant to speed the development of medical devices that patients and caregivers use at home after a hospital stay to help avoid readmission, according to the agency's challenge page. The participants are Epitel, Prapela, BD, Current Health and Skribe Medical, MedTech Dive reported.

The FDA said selection "does not represent FDA marketing authorization and does not guarantee the outcome of any future regulatory submission."

The first five technologies

According to the FDA's list:

• Current Health's CRS Solution is AI/machine learning-based software for healthcare professionals to identify early, and stratify by risk, patients undergoing CAR-T cell therapy who are at increased risk of cytokine release syndrome while being monitored at home.
• Epitel's REMI Neuro Monitoring Home Health Hub is a wireless wearable EEG system for extended monitoring after hospital discharge, for people 6 and older being assessed for seizures, poor sleep or delirium.
• Skribe Medical's Aurora System is a wearable adhesive patch that estimates left ventricular ejection fraction using ECG, heart-sound and chest-vibration sensors, with results sent to a clinician for interpretation.
• Prapela's therapeutic vibrational crib mattress is intended to reduce low-oxygen and slow-heart-rate episodes in infants with single-ventricle heart disease between staged surgeries.
• BD's Self-Collection Kit lets adults collect a capillary blood sample at home for later laboratory testing.

How the challenge works

Companies applied by filing an informational Q-submission, a type of pre-submission to the agency, during a submission period that ran from April 7 to September 30, 2026. The FDA said it may make selections before that window closed and expects to choose up to nine devices from different manufacturers, with all selections notified no later than December 4. Devices described in the submissions may also be considered for breakthrough device designation or the Safer Technologies Program.

Participants move to an interaction phase that includes "sprint" discussions with more frequent FDA feedback on device design and testing for home use, and a chance to demonstrate their technology at the agency's research facilities, the FDA said.

To qualify, a device must address an unmet need in the home, have at least one patient or caregiver as an intended user and be backed by evidence that it may reduce or prevent readmissions. The FDA's page cites thirty-day readmission rates for people with chronic conditions ranging from 2.8% to 18.4%.

The challenge is part of the device center's Home as a Health Care Hub initiative, which CDRH Director Michelle Tarver launched in 2024, MedTech Dive reported.