Today (Monday), Zebra Medical Vision, which leverages Deep-learning AI for medical imaging analytics, announces that it has received a FDA approval for its mammography imaging solution. This becomes the MedTech company's sixth FDA clearance, after also receiving the European CE mark.

Suspicious or not suspicious?

The company's AI-powered solution identifies and prioritizes suspicious mammogram images, which are then analyzed earlier, rather than the "first come, first served" method currently in use. Zebra Medical Vision's mammography solution creates a preventive urgency for medical personnel, while also providing a safety net for radiologists. And, when dealing with cancer urgency and early detection are the "name of the game."

“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,” says Ohad Arazi, CEO of Zebra Medical Vision.

Zebra Medical’s HealthMammo solution is an automatic AI tool that indicates “suspicious” or “not suspicious” for every 2D mammography performed. The images are then immediately sent through an imaging analytics platform, where they are prioritized by severity and signaled to the radiologist within the worklist or on 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.

"As restrictions were lifted... the backlogs of mammograms has increased."

By leveraging automated AI to detect suspicious lesions from mammography exams, the Israeli company's tech is also able to provide, during these frightening times, a necessary tool to combat the fears COVID-19 has caused. With close to 40 million mammograms recorded in the U.S. annually, the rise of the Coronavirus and its anxiety riddled reality, has created an unhealthy fear of hospitals and other medical centers. During the pandemic, this has caused annual exams to be either canceled or postponed, rendering the early detection concept less effective. This runs the risk of creating a mass anxiety of people waiting to be tested, and as screenings are hitting major backlogs with 100,000 being added every day, time is of the essence.

Zebra Medical's imaging solution helps create a secure environment limiting human interaction as well as providing faster crucial results for patients. This helps create a win-win situation where medical centers can provide a safe process and environment for these crucial exams, and patients get results quicker, potentially resulting in more lives saved.

"As restrictions are lifted from the COVID-19 crisis, the backlog of mammograms has increased," says Dr. Michael Fishman, 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.”

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 – CT, x-ray and mammography, providing coverage for roughly 80% of the total imaging volumes.

"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..."

Zebra Medical Vision was founded in 2014 by Eyal Toledano, Elad Benjamin, and Eyal Gura. The company has raised a total of $57 million up-to-date and has already deployed its solutions on 5 continents.