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December 6, 2023
/PRNewswire/ -- OtoNexus Medical Technologies, the developer of the Novoscope ultrasound otoscope for immediate and automatic differentiation of bacterial...
October 16, 2023
After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs.
October 13, 2023
After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs. If...
September 13, 2023
UroMems announced today that it successfully completed enrollment in its first-in-human study of its UroActive system.
June 9, 2023
UroMems announced that it successfully met the primary endpoints for the initial male patient in a study of its UroActive smart implant.
June 6, 2023
/PRNewswire/ -- UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it...
March 7, 2023
/PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a Letter...
November 9, 2022
The U.S. Food and Drug Administration’s (“FDA” or “the Agency”) Center for Devices and Radiological Health (“CDRH”) recently announced the launch of its Total Product Life Cycle...
October 12, 2022
Device Intended to Reduce Risk of IV Catheter Failure and Replacement in Hospitals Recognized by Pediatrics Consortium, FDAOKLAHOMA CITY--(BUSINESS WIRE)--#IVdislodgement--Linear Health Sciences, developer of the Orchid SRV tension-activated breakaway safety release valve, has been recognized for leading the way to...
October 12, 2022
Medicare will likely pick up the bulk of the tab on both treatments (keeping in mind one approval hasn’t happened yet).