Fujifilm gets FDA clearance for endoscopy imaging system

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Fujifilm Medical Systems received 510(k) clearance from the FDA for its Oxygen Saturation Endoscopic imaging system, the company announced July 8.

The system was developed to improve visualization for gastrointestinal, colorectal and endoscopy procedures, according to a July 8 news release. It detects hemoglobin oxygen saturation levels in tissue to help surgeons identify potentially ischemic tissue and prevent tissue necrosis.

"The prognosis is poor for tissue necrosis resulting from GI procedural complications and the reduction in mortality relies on early detection and intervention," Taisuke Fujita, vice president of endoscopy said. "We’re thrilled to have evolved our image enhancement capabilities to address this deadly complication."

In June Fujifilm launched its Systems Integration platform for endoscopies.

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