Facility Inspection Leads To FDA Warning For iRhythm
Executive Summary
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.
You may also be interested in...
Cardio Conversations: ‘Much More Than Just A Patch,’ iRhythm CEO Blackford Talks AI Arrhythmia Diagnostics
iRhythm CEO Quentin Blackford returned to Medtech Insight’s Cardio Conversations podcast to talk about the launch of his company’s new Zio monitor patch supported by a sophisticated neural network. He also addressed the company’s plans to improve its position in the mobile cardiac telemetry market, the impact of pulsed field ablation on the cardiac monitoring business, and more.
MDIC Quality Summit Unveils New Risk-Based Framework, ‘Safe Space’ Recall Initiative
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.
News We’re Watching: AI Safety Partnership; Boston Scientific Recalls; New Cancer, STI Tests; VR
This week, the US and UK announced a partnership to promote AI safety. Boston Scientific recalls embolic agent. LumiCell received FDA approval for its imaging agent to detect residual cancer. Scout receives an award to develop an STI test; and Osso VR leverages the Apple Vision Pro for VR medical training.