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The spacer allows for adjustment of up to 20 degrees in the inward curve of the spine with a disc restoration height range of up to 8 millimeters. Read More
Pure-Vu was previously cleared for use with standard and slim colonoscopes to improve visualization during colonoscopies by irrigating the colon and removing debris. Read More
The company is currently conducting a randomized, multicenter pivotal study for the device. The study, which began in May 2020, will continue at up to 25 U.S. sites. Read More
The system features wireless capabilities, including a hospital connectivity tool, a mobile app for home use and a cloud-based web management platform for healthcare providers. Read More
A clinical trial in metastatic prostate cancer patients found that the software’s sensitivity was 92 percent for regional lymph nodes, 91 percent for distant lymph nodes and 87 percent for bone, the company said. Read More
The agency kicked off the Quality in 510(k) Review pilot in September 2018 with the goal of simplifying how devicemakers submit certain 510(k) notifications. Read More