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The company continued to ship Tablo for use by healthcare professionals in chronic and acute care settings while the hold was in place for home use. Read More
The use of Michelson Diagnostics’ VivoSight Dx multi-beam laser scanner in diagnosing skin cancer reduced the number of consultations and invasive procedures by 66 percent as compared to a standard “punch” biopsy, a Dutch research team reported in the journal The Lancet Oncology. Read More
Sanofi has failed to convince a federal appeals court that Viatris (formerly Mylan) monopolized the market for epinephrine auto-injectors through anticompetitive pricing for its EpiPen. Read More
Device Daily Bulletin Premium takes an in-depth look at the reauthorization of the Medical Device User Fee Act (MDUFA) and how its fifth iteration is taking shape. MDUFA V would reauthorize user fee programs for medical device and diagnostic products from fiscal year 2023 through 2027.Read More
Part of a strong postmarket surveillance system is a good adverse event reporting system. Any company selling an FDA-regulated product of any kind must have an adverse event reporting system in place, including a database designed to manage the collected reports. Read More