Every year, tens of thousands of women who undergo breast-conserving surgery — a lumpectomy — are called back for a second operation.
The reason: the surgeon removed the tumour, but couldn't be completely sure in the operating theatre whether all the cancer was gone. The margins — the edges of the tissue removed — are sent to a pathology lab. The results come back days later. And sometimes, they show that cancer cells remain near the edges. A second surgery is scheduled.
It is one of the most common and emotionally gruelling experiences in cancer care: believing it's done, and then discovering it isn't.
The FDA has just approved a device designed to change that.
**Introducing Claire**
**Claire** — formerly known as Perimeter OCT B-Series with ImgAssist AI 2.0 — is the first AI-enabled intraoperative imaging device approved by the FDA for breast cancer margin assessment. Developed by **Perimeter Medical Imaging AI**, it gives surgeons the ability to assess surgical margins in real time, while the patient is still on the operating table.
The technology uses **optical coherence tomography (OCT)** — a non-destructive imaging technique that uses light waves to generate detailed cross-sectional images of tissue at near-microscopic resolution. Think of it as an ultrasound, but with light instead of sound, and at far higher resolution. When combined with AI analysis, Claire can highlight regions of tissue where cancer cells may be present near the surgical margin.
If the AI detects concerning areas, the surgeon can immediately remove additional tissue — right then, during the same operation — before closing the wound.
**The Numbers Behind the Problem**
Approximately **20–40% of breast-conserving surgery patients** currently require re-excision — a second operation — due to positive or close margins identified after the fact by pathology.
In the United States alone, that translates to an estimated **60,000 to 80,000 unnecessary second surgeries per year**.
Each re-excision means additional anaesthesia, additional surgical risk, additional recovery time, additional emotional burden — and weeks of uncertainty between the first and second procedures. For many patients, this waiting period is one of the most psychologically difficult parts of their cancer journey.
**FDA Approval: What It Means**
The FDA's approval of Claire as an AI-enabled device represents a regulatory milestone. It is the first time the agency has approved an AI imaging system for use during surgery in real time to assess cancer margins — as distinct from post-operative analysis.
Claire has received de novo classification, establishing a new regulatory pathway for this category of device. Other developers working on similar technologies now have a clear framework within which to seek approval.
'This represents a meaningful step forward in how we approach breast-conserving surgery,' said a representative from the surgical oncology community commenting on the approval. 'Having real-time, AI-assisted visibility of margins while the patient is on the table changes the decision-making calculus fundamentally.'
**What Patients Should Know**
Claire will not be instantly available at every hospital. Initial rollout will be gradual, with adoption likely fastest at major cancer centres. The device requires surgeon training in interpreting the AI-assisted imaging alongside traditional clinical judgment.
Importantly, Claire is a decision-support tool — it assists the surgeon's judgment, not replaces it. The FDA's approval framework is built around this 'human in the loop' model.
But the direction of travel is clear: surgery is becoming smarter, faster, and more precise. And for the tens of thousands of women who currently face re-excision every year, the era of 'we'll have to wait and see' may be coming to an end.
The AI that sees cancer during surgery is now approved. 🩺
Sources: AdvaMed · Perimeter Medical Imaging AI · FDA · Journal of Clinical Oncology