News | Breast Imaging | July 27, 2020

This latest clearance makes Zebra Medical the first AI startup with six FDA clearances across three different modalities under its belt

Zebra Medical Vision announced its sixth FDA 510(k) clearance for its mammography solution, HealthMammo, which has already received a CE mark. Zebra Medical’s algorithm empowers breast radiologists by prioritizing and identifying suspicious mammograms, providing a safety net for radiologists. The suspicious mammograms are identified faster and read earlier than the current “first-in first-out” standard of care. 

July 26, 2020 —  Zebra Medical Vision announced its sixth FDA 510(k) clearance for its mammography solution, HealthMammo, which has already received a CE mark. Zebra Medical’s algorithm empowers breast radiologists by prioritizing and identifying suspicious mammograms, providing a safety net for radiologists. The suspicious mammograms are identified faster and read earlier than the current “first-in first-out” standard of care. 

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 – computed tomography (CT), X-ray and mammography, providing coverage for roughly 80% of the total imaging volumes.

Breast cancer is the most frequently diagnosed cancer among women, impacting 2.1 million women worldwide each year and causing the greatest number of cancer-related deaths among women. It is estimated that 627,000 women died from breast cancer in 2018, approximately 15 percent of all cancer-related female deaths. While breast cancer rates are higher among women in more developed regions, rates are increasing in nearly every region globally.

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 helps health providers minimize the COVID-19-induced care gaps with an automated AI tool that can identify faster patients with suspicious lesions. According to the United States Food & Drug Administration (FDA) Mammography Quality Standards program (MQSA), approximately 40 million mammograms are performed in the U.S. every year. With the outbreak of coronavirus, annual mammography tests during lockdown were postponed or canceled. As a result, providers are dealing with substantial growing backlogs, as 100,000 screens are added every day in the US alone, in addition to a 94% drop in mammography imaging volumes during lockdown. Patients are experiencing increasing anxiety waiting to be tested and run the risk of missing the early detection component of annual screening which could result in an undetected cancer that keeps growing.  

“As restrictions are lifted from the COVID-19 crisis, the backlog of mammograms has increased,” said Michael Fishman, M.D., Breast Imaging Section Chief at Boston Medical Center (BMC), Massachusetts. “Zebra Medical Vision’s HealthMammo may help radiologists deal with the screening management strategy of the post COVID backlog and triaging.”

“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. “The fact that during initial testings we were able to identify 2 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 effected reality we are all facing. We’re proud of the achievements we’ve made in the past few months, providing U.S. healthcare with a growing portfolio of automatic solutions to enhance patient care, especially during these times.” 

For more information: www.zebra-med.com


Related Content

News | Breast Imaging

February 22, 2024 — The FAST-Forward randomized trial from the UK found that ultrahypofractionated whole breast ...

Time February 22, 2024
arrow
Feature | HIMSS | Christine Book

February 22, 2024 — With just weeks to go before HIMSS 2024, the Global Conference and Exhibition of the Healthcare ...

Time February 22, 2024
arrow
News | Artificial Intelligence

February 22, 2024 — Hartford HealthCare has announced the unveiling of its Center for AI Innovation in Healthcare ...

Time February 21, 2024
arrow
Videos | Information Technology

Industry trade shows and conferences seem to be making their comeback in 2024. And the Healthcare Information and ...

Time February 21, 2024
arrow
News | Breast Imaging

February 20, 2024 — Annual breast cancer screening beginning at age 40 and continuing to at least age 79 results in the ...

Time February 20, 2024
arrow
News | FDA

February 15, 2024 — Merit Medical Systems, Inc., a global leader of healthcare technology, has received US Food and Drug ...

Time February 15, 2024
arrow
News | Quality Assurance (QA)

February 12, 2024 — IBA, a world leader in particle accelerator technology and a world-leading provider of dosimetry and ...

Time February 12, 2024
arrow
Sponsored Content | Videos | Digital Radiography (DR)

Agfa Radiology Solutions is committed to enhancing clinical outcomes and operational efficiency, underscoring its ...

Time February 12, 2024
arrow
News | Breast Imaging

February 9, 2024 — An innovative breast imaging technique provides high sensitivity for detecting cancer while ...

Time February 09, 2024
arrow
News | Artificial Intelligence

February 8, 2024 — Paige, a global leader in end-to-end digital pathology solutions and clinical Artificial Intelligence ...

Time February 08, 2024
arrow
Subscribe Now