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Tag: iRhythm

Industry Focus Areas, Medical, Regulations

FDA hits iRhythm with warning letter over problems at heart monitor facility

June 1, 2023

Via: MedTech Dive

FDA inspectors concluded their assessment of iRhythm’s facility in Cypress, Calif. in August 2022. The FDA visit led to a Form 483 later that month. iRhythm took steps to address the concerns raised in the 483 but its actions failed […]