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French diagnostics giant bioMérieux is acquiring San Jose, Calif.-based Specific Diagnostics, a company that has developed a rapid antimicrobial susceptibility test (AST) used to identify and quickly treat patients infected with antimicrobial-resistant pathogens. Read More
The FDA has released two final guidances outlining a new product review pathway for developers of facet-screw systems and denture-base resins. Read More
Due to a spring holiday, FDAnews Device Daily Bulletin Premium will not be published Friday, April 15. The next issue will be published Monday, April 18. Read More
Patients with tricuspid regurgitation showed significant improvements in heart-blood flow one year after receiving Edward Lifesciences’ investigational Pascal transcatheter tricuspid-valve repair system, researchers reported. Read More
The primary complaint in FDA warning letters featuring corrective and preventive action (CAPA) citations is that, although the devicemaker had established CAPA procedures, it did not follow or document them properly. Read More
Inivata released data at the American Association for Cancer Research Annual Meeting this week demonstrating the potential of its RaDaR assay for the detection of minimal residual disease (MRD) in cancer and its recurrence. Read More
Abbott subsidiary St. Jude faces a new trial over patent claims by Niazi Licensing concerning a double catheter for the treatment of heart failure after an adverse ruling Monday by the U.S. Court of Appeals for the Federal Circuit. Read More
Magnolia Medical Technologies’ Steripath device reduced blood sample contamination rates by 81 percent hospitalwide in a study, according to researchers at a hospital in West Virginia. Read More