Medical imaging analytics company Zebra Medical Vision has secured FDA 510(k) approval for its mammography solution, HealthMammo.
The automatic AI tool has already been granted a CE mark approval in Europe.
The current regulatory approval marks the company’s sixth FDA approval across three imaging modalities, including CT, x-ray and mammography, and its first FDA approval in the oncology field.
Zebra Medical said that its algorithm is designed to support breast radiologists by prioritising and rapidly identifying suspicious mammograms.
HealthMammo automatically sends mammograms to Zebra Medical’s imaging analytics platform
Part of Zebra Medical’s AI1 (All-In-One) bundle, HealthMammo solution is an automatic AI tool designed to indicate suspicious or not suspicious case for every 2D mammography performed.
The mammograms are automatically sent to the company’s imaging analytics platform, for processing and analysis for suspected breast lesions. The results are sent to the radiologist, either by signaling within the worklist or by notifying the user in a dedicated application.
The algorithm facilitates use in single reader paradigms, for triage and workflow improvement or in double reading paradigms, available outside of the US, supporting second radiologists and reducing the workload.
Zebra Medical claimed that its solution supports early detection protocols and enables health providers to minimise the Covid-19-induced care gaps with an automated AI tool, capable of quickly identifying patients with suspicious lesions.
Boston Medical Center (BMC) breast imaging section chief Michael Fishman said: “As restrictions are lifted from the COVID-19 crisis, the backlog of mammograms has increased. Zebra Medical Vision’s HealthMammo may help radiologists deal with the screening management strategy of the post COVID backlog and triaging.”
In May, Zebra Medical secured the FDA 510(k) approval for its Vertebral Compression Fractures (VCF) solution.
The VCF solution can be used to perform abdominal or chest CT scan for any clinical indication.
