Olympus says CMS recently took a significant step forward to boost colorectal cancer care in the U.S. CMS, on Nov. 1, announced that it will eliminate Medicare cost-sharing for a follow-up colonoscopy after an at-home stool test returns a positive result. Defining such colonoscopies as preventative services means that Medicare beneficiaries will no longer have […]
Colonoscopy
AI-aided colon cancer tech gets FDA nod
Cosmo Pharmaceuticals announced today that it received marketing authorization for its GI Genius AI-based lesion detecting system. GI Genius is an intelligent endoscopy system that uses AI/machine learning to detect lesions in the colon such as polyps or suspected tumors in real-time during a colonoscopy, according to a news release. The device, which received FDA […]
This snake-like robot could be used for colonoscopies
Ben-Gurion University researchers are working on creating an ingestible snake-like robot that can navigate through the small intestine for a robotic colonoscopy. The tiny, swallowable robot, deemed SAW (single actuator wave-like robot), moves in a wave motion and is able to move through the environment of the small intestine. “The external shape of the robot […]
Check-Cap plans $27m round for low-dose X-ray imaging capsule
Check-Cap announced plans to raise approximately $27 million with a $15 million initial public offering and a $12 million private placement, saying it will use the proceeds to develop its ingestible low-dose X-ray imaging capsule.
Given Imaging’s PillCam Colon wins FDA clearance
Given Imaging (NSDQ:GIVN) said it won 510(k) clearance from the FDA for its PillCam Colon, a modified version of its PillCam device.
Avantis raises $5M in debt round for Third Eye endoscope
Avantis Medical Systems said it brought in $4.8 million of a hoped-for $10.6 million debt round.
Sunnyvale, Calif.-based Avantis makes catheter-based endoscopic devices designed to detect and treat and gastrointestinal cancers, according to its website. It’s flagship product is the Third Eye "retrospect" for colonoscopies.
Pentax and Smart ink colonoscopy deal
Under the terms of a new agreement Pentax Medical plans to commercialize its G-Eye endoscope in Europe, the Middle-East and Africa.
The endoscope utilizes Smart’s G-Eye balloon and the HD+ PENTAX Medical colonoscope in order to “centralize the image in the colon lumen and flattens colon folds, thereby providing enhanced visualization of the colon and enabling an increase in polyp detection,” according to a press release.
FDA panel backs computed tomography for colon cancer
Dr. Ronald M. Summers, Diagnostic Radiology Department,
Clinical Center, National Institutes of Health
An FDA panel yesterday agreed that computed tomography colonography should be a screening option offered to asymptomatic colorectal cancer patients over age 50.
FDA win for Given Imaging’s 3rd-gen PillCam
Israel-based Given Imaging is slated to roll out its next-generation PillCam, a capsule-sized camera device used to monitor various GI diseases, after winning 510(k) clearance from the FDA.
FDA panels form joint meeting to consider colorectal cancer screening
A pair of FDA advisory committees planned a joint meeting to discuss the pros and cons of computed tomography colonoscopy as a method of scanning asymptomatic patients for colorectal cancer, according to a notice in the Federal Register.
The FDA’s Gastroenterology-Urology Panel and the Radiological Devices Panel will join forces to advise the FDA on continuing regulation on the topic, meeting in a public forum open to "interested persons" who may present data and opinions, either in writing or orally during the meeting.
Mass. Senate hopefuls on both sides of the party line oppose device tax | MassDevice.com On Call
MASSDEVICE ON CALL — U.S. Senate hopefuls vying for a seat in the Massachusetts campaign agree on 1 point: opposition to the medical device tax. Both Reps. Edward Markey (D) and private equity investor Gabriel Gomez (R) expressed disapproval of the 2.3% excise tax on medical device companies during the recent emphasis on tax policy on the campaign trial this week.
