How 3 FDA Breakthrough Designations accelerate patient care and scale diagnostic AI. * learn * blog * how 3 FDA Breakthrough Designations accelerate patient care and scale diagnostic AI. Table of contents. 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 Aidoc is 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(TM) 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(TM) Chest X-Ray Triage[1]. * 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) clearance[2] 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(TM)- 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. Its 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. * Breakthrough Device Designation (Q262285)) granted for two life-threatening findings | * The CARE(TM) Chest X-Ray Triage 510(k) is currently under FDA's review (K263226).

Solving for distance: How Aidoc is supporting radiology across New Zealand. * learn * blog * solving for distance: how Aidoc is supporting radiology across New Zealand. New Zealand's healthcare system faces a challenge familiar to many countries with dispersed populations: hospitals don't always have a radiologist on site, and the specialists who can interpret complex, time-critical scans are often based hours away. For a patient presenting with a possible stroke, pulmonary embolism, or intracranial hemorrhage in a rural or regional facility, the minutes lost waiting for a distant specialist to review a scan can have life-altering implications. That's where Aidoc comes in. Aidoc's AI-powered clinical decision support tools flag time-critical findings the moment a scan is acquired, prioritizing the worklist so the most urgent suspected cases reach a radiologist's attention first - regardless of whether that radiologist is on site or reporting remotely from another city. For onsite clinical teams, it means immediate visibility into findings that need attention now. For the remote and teleradiology specialists that many New Zealand clinics rely on, it means the right cases surface first, cutting through the queue that distance and workforce shortages create. Three years of partnership, and a new frontier in breast imaging Aidoc has been used at Astra Radiology in New Zealand for three years - and in that time, the relationship has grown from a few point solutions into something closer to a full platform. Astra, part of Integral Diagnostics (IDX), now leverages the majority of Aidoc's solutions, steadily adding new capabilities as its needs have evolved. Two years ago, that meant deploying Aidoc's partner solution with Riverain for lung nodule detection and measurement, giving radiologists an added layer of vigilance on chest CT. A few months ago, Aidoc extended the partnership again with the go-live of its partner solution, Screenpoint for AI-powered breast lesion identification, giving breast imaging specialists a similar layer of support in the detection of suspicious findings on mammography. Taken together, it's a partnership that has expanded almost as fast as Aidoc's own platform has - a sign of how deeply AI-powered decision support has been woven into Astra's day-to-day practice. Sharbell Hashoul, MD, the breast radiologist leading the rollout at Astra Radiology, shared his perspective on what this means for patients and practice: "Breast imaging demands precision and consistency, read after read. Having an AI tool that flags suspicious findings alongside my own interpretation gives me an added layer of confidence - and for our patients across Auckland, that translates into more consistent, earlier detection. It's exactly the kind of support that lets us focus more of our attention where it matters most." - Sharbell Hashoul, MD, Breast Radiologist, Astra Radiology Pioneering the Future of Radiology Reporting Aidoc is excited to share that Aidoc is in advanced development stages of a radiology reporting solution, First Read for Chest X-ray*. Built on the proprietary CARE(TM) foundation model, First Read is intended to analyze chest X-rays across a broad range of findings and generates a preliminary report draft, giving radiologists a head start on reporting while keeping them fully in control of review, adjustment, and final sign-off. First Read for Chest X-ray is still working through regulatory clearance, and Aidoc'll share more as it becomes available in New Zealand. From flagging life-threatening findings in the emergency setting, to catching lung nodules and breast lesions that might otherwise wait for a second look, to its innovation pipeline with First Read reporting, Aidoc's work in New Zealand reflects a simple goal: making sure geography and workforce constraints don't stand between patients and the specialist attention they need. Aidoc will be exhibiting at the RANZCR 2026 annual Scientific Meeting from 22-24 October 2026 at Te Pae Christchurch, and would love to meet in person to discuss how Aidoc can support clinical teams and radiologists in New Zealand. *First Read for Chest X-ray is currently under development and is not available for sale or commercial use in any geography.

Twelve US health systems have formed the Diagnostic AI Consortium with Aidoc to improve the safety, quality and speed of medical diagnosis. Members including Advocate Health, Cedars-Sinai, and Mount Sinai collectively care for nearly 20 million patients annually. The consortium launches amid a growing diagnostic capacity crisis. Outpatient imaging interpretation times more than doubled between 2014 and 2023, whilst radiologists have been leaving the field at 50% higher rates since 2020. The group will co-design AI-enabled diagnostic workflows, measure their impact across member sites, and develop shared implementation practices. Aidoc, which operates in nearly 2,000 hospitals and analyses 60 million patient cases yearly, will provide technical infrastructure through its CARE foundation model and aiOS operating system. Initial results are expected in 2027.