NeoGuide Systems, Inc.'s computer-assisted colonoscopy system has received FDA 501(k) marketing clearance. The company's NeoGuide Endoscopy System is designed to eliminate the "looping" that may occur when the advancing endoscope displaces the colon and stretches the surrounding tissue.
LOS GATOS, CaliforniaNeoGuide Systems, Inc.'s computer-assisted colonoscopy system has received FDA 501(k) marketing clearance. The company's NeoGuide Endoscopy System is designed to eliminate the "looping" that may occur when the advancing endoscope displaces the colon and stretches the surrounding tissue. The system is built of multiple segments that can be actively controlled. As the NeoGuide scope is inserted, the system automatically creates a 3-D map of the colon and directs these segments to follow the path taken by the tip. Results of a clinical study will be reported at Digestive Disease Week 2006.
FDA Approves Encorafenib/Cetuximab Plus mFOLFOX6 for Advanced BRAF V600E+ CRC
December 20th 2024The FDA has granted accelerated approval to encorafenib in combination with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test.