News | Breast Imaging | July 27, 2020

Zebra Medical Vision Secures its First FDA Clearance in Oncology

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

Rafael Rivero, M.D., Global Head of Medical Affairs at MSI, said: "The importance of MyoStrain cannot be understated because of the test's immense clinical value and ability to quantify intramyocardial dysfunction across 48 segments of the heart. In a six-heartbeat MRI scan, MyoStrain arms physicians with novel clinical information about a patient's heart health."
News | Cardiac Imaging | August 11, 2020
August 11, 2020 — Myocardial Solutions, Inc. and United Imaging, Inc.
Building on its commitment to providing customers with artificial intelligence (AI) solutions that can be utilized across modalities in routine care, Canon Medical Systems USA, Inc. is partnering with Zebra Medical Vision to offer its AI1 automated imaging analysis solutions to help clinicians in the U.S. provide faster, accurate diagnoses for optimized patient care
News | Artificial Intelligence | August 11, 2020
August 11, 2020 — Building on its commitment to providing customers with...
A special issue of the Journal of Medical Imaging and Radiation Sciences features stories about the interpersonal skills beyond the technical aspects to care for and guide patients through medical imaging and radiation therapy procedures

Image courtesy of Canon

News | Patient Engagement | August 11, 2020
August 11, 2020 — "I went into the MRI
The global X-ray devices market is estimated to grow at a CAGR of 5.14% from a market size of USDX10.793 billion in 2019 to a market size of USD14.580 billion by 2025

Getty Images

News | X-Ray | August 07, 2020
August 7, 2020 — The global X-ray devices mark
Results of Journal of the American College of Surgeons study should reassure breast cancer patients who experienced surgical postponements due to COVID-19 pandemic

Association between Time to Operation and Pathological Stage in DCIS & ER+ Breast Cancer. Courtesy of American College of Surgeons

News | Women's Health | August 07, 2020
August 7, 2020 — A new br...

An oncologist practices social distancing while talking to a cancer patient. Image courtesy of University of Michigan Rogel Cancer Center

News | Coronavirus (COVID-19) | August 07, 2020
August 7, 2020 — When COVID-19 struck, health ca