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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
Zimmer Holdings said Thursday that it will acquire orthopedic devicemaker Biomet for $13.35 billion, setting the combined company up as a leader in the $45 billion musculoskeletal market. Read More
BD Biosciences is launching its FACSPresto Near Patient CD4 Counter System in CE mark countries after receiving authorization March 28, the company said Thursday. 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