Zebra Medical Gets FDA Nod For 1st AI-Powered Chest Scan Alert

Israel’s Zebra Medical Vision announced that it received FDA 510(k) clearance for an AI-powered alert based on chest X-rays called HealthPNX. The system alerts radiologists of pneumothorax, also known as a collapsed lung, a condition in which there is an accumulation of gas within the pleural space between the lung and the chest wall.

Founded in 2014 by Eyal Toledano, Eyal Gura, and Elad Benjamin, Zebra uses AI to read medical scans and automatically detect anomalies. Through its development and use of different algorithms, Zebra Medical has been able to identify visual symptoms for diseases such as breast cancer, osteoporosis, fatty liver, and conditions such as vertebral fractures, aneurysms, and brain bleeds.

The company has nine CE marks for its various algorithms and 510(k) FDA clearance for one focused on coronary calcium scoring algorithm, which can detect coronary artery disease (CAD). Zebra has raised over $50 million in venture funding since it was founded five years ago.

The latest FDA clearance, received earlier this month, focuses on an AI alert for “stat” (urgent) findings of pneumothorax and “demonstrates a promising potential to substantially reduce turnaround time and increase the radiologist’s confidence in making this diagnosis,” the company said in a statement. HealthPNX automatically detects findings suggestive of pneumothorax based on CXR or digital radiography (DR) scans and alerts the medical team.

Zebra said pneumothorax is commonly diagnosed by a chest X-ray scan, “though it is one of the hardest to interpret, and is known for high disagreement rates even between experienced radiologists.” Misdiagnosis or late-diagnosis of pneumothorax impacts around 74,000 Americans per year, it added.

HealthPNX, Zebra explained, was trained using millions of images to identify over 40 common clinical findings. “The results… establish a new bar for AI research in medical imaging, demonstrating high rates of agreement between the algorithm and human radiologist experts,” the company said.

In hospitals where Zebra’s “All in one” (AI1) solution is integrated – a service it rolled out 2017 allowing healthcare providers globally to access its algorithms for $1 per scan (in partnership with Google) – the scan is flagged so that radiologist can address it in a timely manner.

Zebra said its AI1 Triage Solution is the first of its kind for both CTs and X-rays, and currently addresses two acute conditions: intracranial hemorrhages (head CTs, FDA pending), and pneumothorax (chest X-rays).

The solution “can save physicians more than 80 percent of the time taken to reach the acute condition, compared to the traditional First In First Out (FIFO) methodology,” Zebra said in the statement.

Zebra Medical CEO and co-founder Eyal Gura said the company was “happy to add this important capability to our All-in-One (AI1) package and add more value to busy radiology departments.”

“Health providers across the US that already use the many Zebra-integrated PACS and worklist systems will be able to easily deploy our triage solution and improve their patient’s care and outcomes,” he added.