Dive Brief:

• The Food and Drug Administration’s device center launched an innovation challenge Tuesday to give patients access to home medical devices to reduce hospital readmissions.
• The Center for Devices and Radiological Health plans to select nine devices from different manufacturers by Dec. 4 for the challenge. Selected companies will have opportunities for early engagement with the FDA, including feedback to help refine device design and testing, and the chance to demonstrate their technology at FDA research facilities. 
• The program, called the Reducing Readmissions through Device Innovation for the Home Innovation Challenge, is part of the device center’s Home as a Healthcare Hub initiative, which started in 2024. The initiative is intended to support innovation for medical devices used in the home, while considering diverse perspectives and people’s living environments.

Dive Insight:

The CDRH aims to reduce readmissions using technologies that support patients and caregivers after a hospital stay. 

Applicants should present devices that are intended to meet an unmet or emerging health need in the home. The intended user for the device should be a patient or a caregiver, not a trained medical professional, and at least one of the intended use environments should be in a home or community environment. The CDRH is also looking for evidence, such as literature or data, to support the feasibility of the device and that it may help reduce or prevent readmissions.

Hospital readmissions can pose significant personal, financial and logistical challenges for patients and caregivers, the CDRH said. The 30-day readmission rate for patients without chronic conditions was 13.9% between 2016 and 2020, with readmissions costing more than the initial hospital stay. People with chronic conditions can face readmission rates as high as 18.4%, according to an analysis of discharge data from 2009 to 2014.

The CDRH will take submissions through Sept. 30, and the selection period will be Oct. 1 to Dec. 4.