Boosting early detection of breast cancer in mammograms, Zebra Medical Vision has announced its sixth FDA 510(k) clearance for its AI mammography solution, HealthMammo, which has already received a CE mark.
This is Zebra Medical Vision’s first solution for Oncology to receive FDA clearance, as part of the company’s AI1 “All-In-One” bundle. Zebra Medical is also the first startup to receive FDA clearances for AI based technology across three imaging modalities – CT, x-ray and mammography, providing coverage for roughly 80% of the total imaging volumes.
Zebra Medical’s HealthMammo solution is an automatic AI tool that indicates “suspicious” or “not suspicious” for every 2D mammography performed. The mammograms are automatically sent to Zebra Medical’s imaging analytics platform, where they are processed and analyzed for suspected breast lesions.
The HealthMammo product then returns its result to the radiologist, either by signaling within the worklist or by notifying the user in a dedicated application.
The algorithm can be used in single reader paradigms, supporting triage and workflow improvement (as cleared by the FDA) or in double reading paradigms, already available outside of the US, supporting the second radiologists and reducing their workload.
Supporting early detection protocols, Zebra Medical Vision’s HealthMammo product is said to help health providers minimize the COVID-19-induced care gaps with an automated AI tool that can identify faster patients with suspicious lesions.