Approval is for new system designed to improve visualization.
Fujifilm Medical Systems, USA, Inc., announced this week that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its Oxygen Saturation Endoscopic Imaging System.
This system is designed to improve visualization for gastrointestinal, colorectal, and advanced endoscopy and surgical procedures.
By enabling the visualization of hemoglobin oxygen saturation (StO2) levels in real time with laparoscopic and/or endoscopic images, company official said, the system can help surgeons identify ischemic tissue. As a result, they could potentially prevent tissue necrosis.
“The prognosis is poor for tissue necrosis resulting from [gastrointestinal] procedural complications and the reduction in mortality relies on early detection and intervention,” says Taisuke Fujita, vice president of Fujifilm’s endoscopy division. “As long-standing leaders in endoscopic imaging, we’re thrilled to have evolved our image enhancement capabilities to address this deadly complication.”
This new system is an upgrade option to the ELUXEO® Surgical System. It will add StO2 visualization mode to the existing Blue Light Imaging, Linked Color Imaging®, and White Light Endoscopy modes. Implementing this new mode can give surgeons even more unique information for better diagnoses during procedures.
This 510(k) clearance comes on the heels of Fujifilm receiving FDA Breakthrough Device Designation six months ago for its endoscopy image enhancement technology.
According to company officials, the system will be available in the United States later this summer and globally later this year.
Interventional Radiology Study Shows Low Breast Cancer Recurrence 16 Months After Cryoablation
March 29th 2024In a cohort of patients with invasive breast cancer and tumor sizes ranging between 0.3 to 9 cm, image-guided cryoablation was associated with a 10 percent recurrence rate at 16 months, according to research recently presented at the Society of Interventional Radiology (SIR) conference.
The Reading Room: Artificial Intelligence: What RSNA 2020 Offered, and What 2021 Could Bring
December 5th 2020Nina Kottler, M.D., chief medical officer of AI at Radiology Partners, discusses, during RSNA 2020, what new developments the annual meeting provided about these technologies, sessions to access, and what to expect in the coming year.
FDA Clears Remote Scanning Support Platform for MRI, CT and PET/CT
March 25th 2024The multimodality system nCommand Lite reportedly facilitates real-time remote imaging guidance on scanning parameters and procedure assessments to licensed technologists for a variety of imaging modalities including CT and MRI.
AI Radiology ROI Calculator Study Projects 451 Percent ROI Over Five Years
March 18th 2024Incorporating an artificial intelligence (AI) platform into the radiology workflow at a stroke management-accredited hospital may lead to projected savings of 78 days in triage time and 41 days in reporting time for radiologists over a five-year period, according to new research.