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FDA clears AI-based system for detecting breast cancerFDA clears AI-based system for detecting breast cancer

Developers claim HealthMammo identified cases missed by radiologists

Chuck Martin

August 3, 2020

2 Min Read

Developers claim HealthMammo identified cases missed by radiologists

The US Food and Drug Administration (FDA) has granted Zebra Medical Vision 510(k) clearance for HealthMammo, its AI-based mammography solution.

The deep learning startup had previously received a CE mark for its software in Europe; the 510(k) clearance recognizes HealthMammo as safe and effective, allowing marketing in the US.

Breast radiologists can use Zebra Medical’s deep learning models to prioritize and identify suspicious mammograms, which can be read earlier and faster than when using the traditional workflow.

The tool labels images as “suspicious” or “not suspicious” in 2D mammography.

Vote of confidence

"As restrictions are lifted from the COVID-19 crisis, the backlog of mammograms has increased,” said Dr. Michael Fishman, breast imaging section chief at Boston Medical Center in Massachusetts. “Zebra Medical Vision’s HealthMammo may help radiologists deal with the screening management strategy of the post COVID backlog and triaging.”

During initial testing, the system was able to identify two cases that were missed, with the women recalled and diagnosed with cancer, according to the company.

In the EU, where every screening mammogram is read by two radiologists, HealthMammo has the potential to eventually replace one of the two radiologists to become an AI-based second reader.

The company has clearance for using AI technology across three imaging modalities of CT, conventional X-ray, and mammography.

“Our work is twofold: supporting the medical team’s overload and ensuring the well-being of patients, by supporting early detection and reducing the anxiety surrounding uncertainty,” said Ohad Arazi, CEO of Zebra Medical Vision. “We aim to help patients and providers navigate the new COVID effected reality we are all facing.”

Zebra Medical has raised $57 million in funding from investors including Khosla Ventures, Marc Benioff, Intermountain Investment Fund, OurCrowd Qure, Aurum, aMoon, and Nvidia.

Breast cancer is the most common cancer in American women, according to the American Cancer Society. An estimated 276,000 new cases of invasive breast cancer are expected to be diagnosed in women in 2020.

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