Facility Inspection Leads To FDA Warning For iRhythm
The US FDA issued a warning letter to iRhythm Technologies related to its Zio cardiac monitor system after an August 2022 inspection of the firm’s California facility. Wells Fargo predicts little impact on the company.
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During a recent summit, the Medical Device Innovation Consortium Case for Quality Collaborative Community introduced a new risk-based CAPA framework that moves away from the current compliance-focused “one-size-fits-all” approach to a more comprehensive strategy. The summit also discussed how the industry can more effectively and quickly notify consumers about recalls.
During a recent listening session on modernizing its recall process, the US FDA heard from industry, consumers, and patients — all of whom expressed a common theme: the agency needs to up its game in how it handles recalls.
News We’re Watching: Free COVID-19 Tests, Edwards Antitrust Investigation, McKinsey Calls For Medtech ‘Reinvention’
This week, the US government relaunched a program providing free COVID-19 tests and invested $600m in domestic test manufacturing; the European Commission revealed an antitrust investigation of Edwards LifeSciences; and a consulting firm report said the medtech industry should make big changes to address investor skepticism.