Developing clinical and diagnostic AI solutions used to take years, if not decades. That time has a cost. The longer that life-changing solutions stay in development, the smaller the opportunity to help current patients who might’ve had better outcomes. That’s why bringing high-quality, clinically meaningful solutions to market faster is crucial, and is thankfully enabled via the FDA’s Breakthrough Device Designations (BDD).
Aidoc recently received a Breakthrough Device Designation (BDD) for CARE Chest X-Ray (CXR) Triage.
This is the third FDA BDD that Aidoc is receiving in just over a year, showing that the FDA sees strong clinical value in what we’re building.
Read on to discover what the BDD means in practice, what this third BDD is for, and what the accomplishment of receiving three BDDs in just over a year signals for the future of scalable diagnostic AI.
Key takeaways:
- The FDA grants Breakthrough Device Designation (BDD) to technologies that offer a more effective diagnosis of life-threatening diseases with no alternative currently available.
- Aidoc’s CARE™ foundation model is accelerating development of new diagnostic AI solutions due to its architecture.
- Aidoc has just received its third BDD in just over a year for solutions developed on the CARE foundation model. This time, the designation is for CARE™ Chest X-Ray Triage1.
- Aidoc continues to develop new radiology workflow solutions on CARE with safety, quality, and accuracy in mind.
- The CARE Chest X-Ray (CXR) Triage solution is pending 510(k) clearance2 and is not yet available for sale in the United States.
About the BDD
The FDA grants Breakthrough Device Designations for technologies that may provide more effective diagnosis or treatment for serious or life-threatening conditions, and address an unmet clinical need. The program can support an expedited development and review process to enable FDA clearance faster.
About the CARE Chest X-Ray Triage solution
The third BDD Aidoc received is for CARE Chest X-Ray (CXR) Triage, a solution designed to help care teams attend to high-volume cases faster and more consistently across the health system. Similar to the other two BDDs that Aidoc received this year, CARE Multi-Triage Body CT in August 2025 and CARE First Read for Chest X-Ray in April 2026, the CARE CXR Triage solution was built on CARE, the first clinical-grade foundation model in healthcare with FDA-cleared solutions. It’s deployed through Aidoc’s aiOS, the operating system that runs, orchestrates, and governs diagnostic AI across health systems.
The broader CARE CXR Triage solution is being developed to support a wider set of findings, all within one workflow. For now, the BDD applies to two clinical findings within a chest X-ray: triage and prioritization of pneumomediastinum, and lobar or lung collapse.
*The CARE CXR Triage solution for prioritization of pneumomediastinum and lobar/lung collapse is pending 510(k) clearance and is not currently available for sale in the United States.
Aidoc’s CARE foundation model accelerates development
Up until recently, development of diagnostic AI happened one use case at a time. A new condition required new data, a new model, new validation, new regulatory approval, and another implementation effort. It took years to achieve single, point-based solutions and made it difficult to scale AI across the range of conditions and workflows that health systems manage every day.
Aidoc’s CARE foundation model offers a different development architecture. CARE can be consistently reused to support accelerated development across:
- Multiple clinical findings and conditions
- Multiple anatomies, including the abdomen and chest
- Multiple modalities, including CT and X-ray
- Multiple clinical workflow tasks, including triage, characterization, measurement, and report drafting.
Combining CARE with Aidoc’s aiOS™ — the diagnostic AI operating system that runs, orchestrates and governs AI across health systems — creates a path to expand coverage without treating every new application as an entirely separate starting point. This platform allows Aidoc to develop these solutions faster than ever.
Idan Bassuk, Aidoc’s Chief R&D and AI Officer, explains the value of accelerated development:
“When building the CARE foundation model, our vision was to get life-changing AI in the hands of clinicians faster than was ever deemed possible. In the perspective of 19 months since launching CARE, we have achieved Breakthrough Device Designations for three devices across different anatomies and modalities. Achieving this, while still meeting the most rigorous safety and quality standards, is what makes CARE different.”
For Aidoc, validation work extends far beyond seeking regulatory approval. Health systems need evidence that a solution can fit into their specific clinical workflows, support their care teams, perform consistently, and create measurable value — not just in terms of ROI or additional reimbursement pathways, but in clinician impact and patient outcomes.
Maintaining the safety and quality standard
A model that performs well for one finding does not automatically meet the requirements for a broader device. Each indication must be evaluated across representative data, clinical settings, and workflow conditions. Each solution must have a clear role for clinicians and a defined path for oversight.
Aidoc continues to develop new CARE solutions with those requirements in mind. Safety and quality are part of the development process, regulatory strategy, clinical validation, and deployment infrastructure.
Standardizing triage and prioritization protocols
Today, health system imaging, including X-rays, is often distributed amongst teams to help reviews move quickly. When imaging is dispersed across groups like trainees, residents, outside reading groups, teleradiology, offshore, and even ED physicians, there’s an inherent risk of producing uneven quality and timeliness.
Aidoc helps bring a standard approach to triaging and prioritizing images across a health system with a safe, effective, clinical-grade solution. Our third Breakthrough Device Designation in just over a year is an important step in that work. It advances CARE-powered solutions to include chest X-rays while maintaining the standards that make clinicians trust Aidoc in practice: evidence, safety, quality, and measurable value.
