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The FDA plans to release a document later this year that will explain how devicemakers can use the agency’s benefit-risk framework for device approval when designing different types of clinical trials, CDRH Director Jeffrey Shuren said Wednesday. Read More
The FDA Tuesday proposed a new, voluntary program to speed the approval of devices that address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions. Read More
Snoqualmie, Wash., devicemaker Spacelabs Healthcare sent an Urgent Medical Device Correction letter to customers March 11, warning of a defect in the version 2.0 software accompanying its Arkon anesthesia delivery system. Read More
DexCom, a San Diego maker of continuous glucose monitors, has been warned over medical device reporting failures and problems with its MDR procedure. Read More
Austen BioInnovation Institute of Akron is teaming up with Cleveland’s Nottingham Spirk to hasten biomedical innovation in Ohio, the groups announced Monday. Read More
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