The FDA Center for Devices and Radiological Health is accepting submissions for the READI-Home Innovation Challenge: Reducing Readmissions through Device Innovation for the Home. The challenge is part of FDA’s Home as a Health Care Hub initiative and is intended to accelerate patient access to medical device technologies used in the home to support patients and caregivers after an acute hospital stay and help prevent avoidable readmissions.
Deadline: submissions remain open through September 30, 2026. FDA’s controlling page does not publish a specific closing clock time or time zone, so Atlas does not infer one. FDA may select participants before the submission period closes and intends to notify selected participants no later than December 4, 2026.
Opportunity value: this challenge does not provide grant funding or cash prizes. FDA anticipates selecting up to nine devices from distinct manufacturers for an interaction phase that provides earlier and more frequent FDA engagement, sprint discussions, feedback on device design and testing for home use, and an opportunity to demonstrate technology at FDA research facilities. Selection does not constitute FDA marketing authorization and does not guarantee the outcome of a future regulatory submission.
Selection gates: the proposed innovation must meet the federal definition of a medical device. FDA prioritizes technologies addressing an unmet or emerging home health care need; having at least one patient or caregiver as an intended user; including the home or community as an intended use environment; having sufficient evidence supporting an association with reduction or prevention of readmissions in the target population; and having sufficient evidence of device feasibility. FDA also asks for device and clinical-challenge description, novelty, current development status and prior FDA communications, a data development plan, team expertise, and anticipated clinical impact.
Atlas fit: N9+ Fit Score 98/100 and Atlas Opportunity Score 97/100, conditional. This is a strong direct-fit federal opportunity for the Nonagon N9+ device and platform if a specific post-discharge home-use pathway can be supported with verified regulatory facts, patient or caregiver usability, feasibility evidence, and credible evidence that the proposed use may reduce or prevent readmissions. No claim is made here that N9+ already satisfies those requirements or has a particular FDA regulatory status.
Submission mechanics: submitters provide a one-page executive summary addressing the five prioritization elements followed by the additional requested information, limited to 16 total pages excluding references. The submission is made as an Informational Q-Submission through the CDRH Portal. FDA instructs submitters to prefix the company name with READI-Home Innovation Challenge and provides required submission-purpose language on the controlling challenge page.
This is classified as a TRUE Dr. Miltie direct-opportunity candidate for review. It should not be auto-submitted. Any pursuit should first verify the current regulatory status and intended use of the Nonagon N9+ device and platform, identify a specific target post-discharge population and readmission mechanism, document supporting evidence and feasibility, and assemble the required data development plan and regulatory narrative.