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Mountain View, Calif.-based Crosscope has teamed up with Germany’s Mindpeak to develop new digital tools designed to improve cancer diagnosis. Read More
The FDA should consider broadening the scope of its draft guidance, “Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology,” device manufacturers said in written comments to the agency on the draft, which was released for comment on Dec. 23, 2021. Read More
So far, the FDA says, it has not received reports of injuries, adverse health consequences or deaths associated with use of ACON Laboratories’ Flowflex SARS-CoV-2 Antigen Rapid Test. Read More
Immunodiagnostics developer Oncimmune has inked a contract with Alphabet subsidiary Verily Life Sciences to conduct autoantibody profiling on patients who have developed long COVID-19, defined as a symptomatic case of COVID-19 that lasts for more than four weeks. Read More
The FDA should go ahead with its plans to overhaul its Quality System Regulation (QSR) to harmonize it with the International Organization for Standardization’s ISO 13485 standard, but should give device manufacturers more than one year to implement the revised regulation, industry speakers said at a meeting of the agency’s Device Good Manufacturing Practice Advisory Committee on Wednesday. Read More
To clarify the FDA’s recommendations on quickly and effectively removing potentially harmful drugs and devices from the market, the agency has published a final guidance focused on recall readiness. Read More