Technology | Artificial Intelligence | May 13, 2019

FDA Approves Zebra Medical Vision's HealthPNX AI Chest X-ray Triage Product

ER and ICU X-rays can now be automatically triaged as acute cases with pneumothorax

FDA Approves Zebra Medical Vision's HealthPNX AI Chest X-ray Triage Product

May 13, 2019 — Zebra Medical Vision has received U.S. Food and Drug Administration (FDA) 510(k) clearance for HealthPNX, an artificial intelligence (AI) alert for pneumothorax (PNX) based on chest X-rays.

The latest FDA clearance, received in May 2019, 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. Chest X-rays are one of the world's most used imaging modalities.

Pneumothorax is a condition in which there is an accumulation of gas within the pleural space between the lung and the chest wall. Without prompt management, pneumothorax can lead to total lung collapse and other potentially fatal complications. This condition is most 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.1

The patent pending technology automatically detects findings suggestive of pneumothorax based on CXR or digital radiography (DR) scans, and alerts the medical team. In hospitals where Zebra-Med's "All in one" (AI1) solution is integrated into the radiologist's worklist, the scan is flagged so that the radiologist can address it in a timely manner. This first-of-its-kind FDA-cleared 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, according to Zebra Medical.

The chest X-ray AI network was trained using millions of images to identify more than 40 common clinical findings. The results of the Textray study demonstrate high rates of agreement between the algorithm and human radiologist experts.2

"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," said Terence Matalon, M.D., chairman of imaging at Albert Einstein Medical Center. Zebra-Med's AI1 Triage Solution is the first of its kind for both computed tomography (CT) scans and X-rays, and currently addresses two acute conditions: intracranial hemorrhages (head CTs, FDA-pending), and pneumothorax (chest X-rays).

For more information: www.zebra-med.com

References

1. Bintcliffe O., Maskell N. Spontaneous pneumothorax. British Medical Journal, May 8, 2014. doi: https://doi.org/10.1136/bmj.g2928

2. Laserson J., Lantsman C.D., Cohen-Sfady M., et al. TextRay: Mining Clinical Reports to Gain a Broad Understanding of Chest X-rays. arXiv, June 6, 2018. 

 

Related Content

Estimates of excess deaths, defined as the number of persons who have died from all causes, above the expected number of deaths for a given place and time, can provide a comprehensive account of mortality likely related to the COVID-19 pandemic, including deaths that are both directly and indirectly associated with COVID-19.
News | Coronavirus (COVID-19) | May 13, 2021
May 13, 2021 — Estimates of excess deaths, defined as the number of persons who have died from all causes, above the
Herman Oosterwijk

Herman Oosterwijk

News | Artificial Intelligence | May 13, 2021
May 13, 2021 — Laurel Bridge Software, a provider of ...
 Novarad, healthcare IT and medical imaging company, has recently entered into contract with Waverly Health Center (WHC) of Iowa to provide its award-winning solution for simply and securely sharing medical images and reports – CryptoChart.
News | Enterprise Imaging | May 12, 2021
May 12, 2021 — Novarad, healthcare IT and medical imaging company, has recently entered into contract with...
News | Artificial Intelligence | May 11, 2021
May 11, 2021 — Whiterabbit, an AI technology company focused on early...
National Imaging Solutions, a recognized leader in medical imaging and radiology solutions, announced it has acquired DynaRad — the oldest manufacturer of portable X-ray systems in the US. This new investment will allow National Imaging Solutions to support its customers by supplying them with DynaRad portable X-ray machines, including a mobile field X-ray device using nanotube technology.
News | Radiology Business | May 11, 2021
May 11, 2021 — ...
New Module Creates a Warped MRI Scan that Matches Real-Time Ultrasound Results (Graphic: Business Wire)

New Module Creates a Warped MRI Scan that Matches Real-Time Ultrasound Results (Graphic: Business Wire)

News | Artificial Intelligence | May 07, 2021