Israeli medical imaging analytics company Zebra Medical Vision has received 510(k) clearance from the US Food and Drug Administration (FDA) for its mammography solution.
Called HealthMammo, the solution uses artificial intelligence (AI) technology to prioritise and detect suspicious mammograms during 2D mammography.
The mammograms are automatically sent to Zebra Medical’s imaging analytics platform where they are processed and analysed for suspected breast lesions.
The tool then returns the result to the radiologist by signalling within the worklist or by notifying the user in a dedicated application.
Breast cancer, which impacts approximately 2.1 million women around the world each year, causes the highest number of cancer-related deaths among women.
Zebra Medical Vision CEO Ohad Arazi said: “The fact that during initial testings we were able to identify two cases that were missed and to have these women be recalled and diagnosed with cancer shows the vast impact and potential contribution of AI in oncology.
“With this fully commercial and regulated product, we aim to provide even more value and help patients and providers navigate the new Covid-19-affected reality we are all facing.”
Last year, FDA cleared the company’s AI-powered HealthCXR device that enables the identification and triaging of pleural effusion in chest X-rays.
In a separate development, Israel-based Rapid Medical has secured CE Mark for its stent retriever TIGERTRIEVER XL.
It is the latest addition to the company’s TIGERTRIEVER portfolio, which consists of adjustable, fully visible clot retrievers designed to treat ischemic stroke. The company has also treated first patients with the device.
Meanwhile, US-based Stratus Medical received FDA 510k clearance for the Vesta RF Cannulafor use in radiofrequency (RF) heat lesion procedures for the relief of pain.
The device was developed to treat pain in clinical scenarios where the company’s Nimbus RF Multitined Expandable Electrode is not indicated.
The clearance enables the company to market its CE-Marked Vesta RF Cannula in the US and continue the expansion into new markets globally.