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The FDA has announced that it will conclude its Quality in 510(k) Review Program pilot after May 30 and will no longer accept submissions after that date, directing companies to consider using its electronic Submission Template and Resource (eSTAR) pilot program instead. Read More
The FDA has reversed a Trump Administration policy that was set to exempt 83 class II devices and one unclassified device from premarket notification requirements. Read More
Adverse events reported in MAUDE alone are an inappropriate basis for exemptions because adverse events may be under reported for certain devices and may not necessarily reflect the risk of injury, the agency noted. Read More
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