Dexcom has been selected as the inaugural participant in the FDA’s new TEMPO Digital Health Devices Pilot Program. This regulatory framework allows manufacturers to market devices for intended uses not yet authorized by the FDA while collecting real-world data for future 510(k) or De Novo submissions.
The TEMPO pilot integrates with the CMS Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. This partnership enables Outcome-Aligned Payments for digital-first care, transitioning the industry away from traditional fee-for-service reimbursement structures.
For Dexcom, this selection provides a unique pathway to market and monetize new technological applications while simultaneously generating data for full FDA clearance. The program is expected to accelerate the innovation and clinical adoption of the company's digital health solutions.