The U.S. FDA’s device center is re-examining its approach to public safety communication, but Mark Leahey of the Medical Device Manufacturers Association said on a recent webinar that the FDA sometimes goes silent after an initial consultation with device makers about a safety signal.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Armis Biopharma, Hologic, Penumbra, Pixium, Think Surgical.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: J&J subsidiary agrees to settle off-label promotion allegations; FDA says ‘vulnerabilities persist’ in limited CDS programs.
Keeping you up to date on recent developments in neurology, including: Wireless chip developed to improve brain research; Diabetes increases damage around amyloid plaques in Alzheimer’s; Smartphone keystrokes show promise in monitoring progression of MS.
Hot on the heels of news that two vaccines for COVID-19 are nearing market readiness, two companies have broken away from the pack of assay manufacturers to offer quantitative antibody tests that can verify whether the vaccines provide effective, lasting protection. Siemens Healthineers and Imanis Life Sciences both claim to be first to develop scalable, quantitative neutralizing antibody tests.
Varian Medical Systems Inc. revealed that the first clinical trial of FLASH therapy has kicked off, with the initial treatment taking place at the Cincinnati Children's/UC Health Proton Therapy Center. The study, which saw the first patient treated this week, involves the investigational use of Varian's Probeam particle accelerator modified to enable radiation therapy delivery at ultra-high dose rates.
RSS
