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January 25, 2024
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FDA grants 510(k) clearance to AI-based lung segmentation software

Fact checked byKristen Dowd
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The FDA has granted 510(k) clearance to LungQ 3.0.0, an artificial intelligence-based software that identifies different parts of lung anatomy and evaluates lung tissue and fissure completeness, according to a press release.

With use of this version of LungQ (Thirona), the release said physicians will feel supported when diagnosing and documenting pulmonary tissue images since the software identifies and separates pulmonary segments and subsegments.

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The FDA has granted 510(k) clearance to LungQ 3.0.0, an artificial intelligence-based software that identifies different parts of lung anatomy and evaluates lung tissue and fissure completeness, according to a press release.
Eva van Rikxoort

“The FDA 510(k) clearance for Thirona’s LungQ version 3.0.0 Software translates to more personalized and localized treatment of patients,” Eva van Rikxoort, PhD, founder and CEO of Thirona, told Healio.

“For example, for patients undergoing surgery for lung cancer, by having precise delineation of the lung segments, doctors can [target] the lung segments in which the tumor resides instead of lung lobes, saving more healthy lung tissue of patients,” van Rikxoort said.

One of the first versions of this software (1.1.0) was previously granted FDA clearance in 2018, and more than 600 hospitals are now using LungQ.

According to the release, the software has been validated in more than 200 publications.

When asked about the future of AI in health care, van Rikxoort told Healio she believes it will become a necessity and will be markedly important in lung image analysis and treatment.

“When humans work alone to identify lung structures, patients often undergo invasive procedures that can deplete their lung function capacity,” van Rikxoort said. “With the addition of AI, patients are being diagnosed and treated more accurately. As AI continues to accelerate innovation and enhance the treatment of patients, it is no longer going to be optional in health care settings.”