Zebra Medical receives FDA clearance for AI chest X-ray product

14 May 2019 (Last Updated December 23rd, 2019 10:22)

Israeli company Zebra Medical Vision has secured 510(k) clearance from the US Food and Drug Administration (FDA) for an artificial intelligence (AI)-powered chest X-ray triage product.

Zebra Medical receives FDA clearance for AI chest X-ray product
Zebra Medical Vision receives FDA approval for world’s first AI chest X-ray triage product. Credit: PRNewsfoto/Zebra Medical Vision.

Israeli company Zebra Medical Vision has secured 510(k) clearance from the US Food and Drug Administration (FDA) for an artificial intelligence (AI)-powered chest X-ray triage product.

Named HealthPNX, the product is designed to provide an AI alert for urgent findings of pneumothorax. The company said that the technology showed potential to reduce turnaround time.

Pneumothorax is characterised by accumulation of gas within the space between the lung and the chest wall that can lead to total lung collapse. It is usually diagnosed by chest X-ray scan but is difficult to interpret.

Misdiagnosis or late diagnosis of the condition is known to impact nearly 74,000 people in the US per year.

“Zebra-Med’s acute CXR pneumothorax and CT Brain bleed products demonstrated potential to reduce turnaround time and increase the radiologist’s confidence in making diagnoses.”

HealthPNX analyses CXR or digital radiography (DR) scans to automatically detect findings that indicate pneumothorax and notifies the medical team.

Compared to the standard First In First Out (FIFO) approach, the AI solution is claimed to save more than 80% of the time taken to reach the acute condition.

Chairman of Imaging at Alvert Einstein Medical Center Dr Terence Matalon said: “In a clinical validation study we performed, Zebra-Med’s acute CXR pneumothorax and CT Brain bleed products demonstrated a promising potential to substantially reduce turnaround time and increase the radiologist’s confidence in making these diagnoses.”

Using millions of images, the product was trained to identify more than 40 common clinical findings. Results from the Textray study showed high agreement rates between the algorithm and human radiologist experts.

Zebra Medical Vision CEO and co-founder Eyal Gura said: “We are 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 patients’ care and outcomes.”