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Florida’s RTI Surgical is launching its Streamline OCT spinal fusion system in the U.S. after receiving 510(k) clearance last month, the company said Monday. Read More
The FDA is creating tough new standards for clinical trials that use live case presentations, requiring that devicemakers discuss all potential risks and benefits in their investigational plans. Read More
LumiQuick Diagnostics received an FDA warning letter after an investigator saw employees assembling a drugs of abuse test panel and an amphetamine test strip on the same table. Read More
Laparoscopic devices commonly used to treat uterine fibroids could spread cancerous tissue, the FDA said Thursday in a safety communication discouraging the use of the procedure. Read More
Heart patients in the U.S. would no longer have access to Medtronic’s CoreValve transcatheter valve if a preliminary injunction handed down in federal court takes effect. Read More