Zebra Medical Vision lands FDA approval for AI pneumothorax alert product
Zebra Medical Vision, an Israeli medical imaging analytics company, has received FDA 510(k) clearance for a product called HealthPNX, which provides an AI alert for pneumothorax based on chest X-rays.
The clearance was received this month.
Pneumothorax is a condition in which there’s an accumulation of gas in the pleural space between the lung and the chest wall. It’s commonly diagnosed via a chest X-ray scan but is hard to interpret. If it’s not managed quickly, it can lead to a total lung collapse or other complications.
Zebra’s patent-pending technology automatically flags findings suggestive of pneumothorax based on chest X-rays or digital radiography scans and informs the medical team. The chest X-ray AI network was trained using millions of images to pinpoint more than 40 common clinical findings, according to a news release from Zebra.
“We are happy to add this important capability to our All-in-One (AI1) package and add more value to busy radiology departments,” Zebra Medical Vision co-founder and CEO Eyal Gura said in a statement. “Health providers across the U.S. 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.”
In July 2018, the Israeli company received FDA approval for its coronary calcium scoring algorithm, which can detect coronary artery disease. The startup also has nine CE marked products.
Zebra’s future plans include expanding its reach in the United States and releasing additional automated tools.
The company was founded in 2014. In 2016, it announced the launch of a patient-facing tool called Profound. The offering allows people to upload their medical imaging scans (like computerized tomography scans and mammograms) to Zebra’s online service and receive an automated analysis of key clinical conditions.
That same year, the company landed $12 million in a funding round led by Intermountain Healthcare. Other investors included Dolby Family Ventures, Israeli crowdfunding business OurCrowd, Salesforce CEO Marc Benioff and Khosla Ventures.
Original Article: (https://medcitynews.com/2019/05/zebra-medical-vision-fda-approval/)