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GE Health Unit wins first FDA approval for AI-powered X-ray system

The Food and Drug Administration has cleared a new artificial intelligence x-ray device that manufacturer GE Healthcare says reduces the time to diagnose and treat a collapsed lung from eight hours to as little as 15 minutes, the company announced Thursday.

The device, called the Critical Care Suite, uses AI algorithms to scan x-rays and detect pneumothorax, a deadly condition known as a collapsed lung that affects approximately 74,000 Americans each year.

"The health industry produces huge amounts of data from images to digital health records," said GE Healthcare CEO Kieran Murphy in an interview with CNBC prior to the announcement. "We strongly believe that you need to turn this data into information and insight to improve results."

GE Healthcare, a dominant player in hospital and lab equipment, said its goal is to integrate AI into all aspects of the healthcare system to ultimately "improve patient outcomes, reduce waste and inefficiency, and eliminate costly errors."

The General Electric unit's technology, developed with researchers at the University of California, San Francisco, is trained to detect pneumothorax, but the company said it is working to improve it to detect other health conditions.

The technology works by using AI to analyze images from an X-ray image, the company says. If a condition is suspected ̵

1; in this case, pneumothorax – the image is sent directly to the radiologist for review. The technology works outside the cloud and is not dependent on an internet connection, the company says.

"At present, 62% of portable breast exams are labeled" STAT "or for urgent reading, but they are not all critical," said Jie Xue, President and CEO of the company's X-ray department. "This creates a delay in turning for really critical patients, which can be a serious issue."

FDA approval comes at a time when AI is expanding across the medical field and helps physicians quickly analyze a range of illnesses and diseases, reducing cost and inefficiency. While there is optimism, there are also concerns about technology making major medical decisions.

"There is no suggestion that you replace the radiologist," Murphy said in the interview. "Of course [the radiologist] will check that they agree with the conclusion. But so far, the accuracy of large pneuomothroax is 96% and a very low number of false and is of course also a problem."

The unit is expected to hit the US market this year.

The care unit has grown dramatically from its origins in 1896 when it began to develop x-rays. The company has become a leader in the field of medical care. It is already a dominant player in hospital and laboratory equipment and is a growing force in medical records, software for health care and has expanded its brand of gene therapy research.

In February, GE announced plans to sell its biopharmaceutical portion to industrial company Danaher for $ 21.4 billion.

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