Outset Medical (OM) announced it has been notified by the FDA that all issues cited in a warning letter the company received in July of 2023 have been addressed. “A commitment to innovation and the advancement of better outcomes in dialysis remains at the core of Outset, which makes the quality of our products and regulatory compliance essential to our company’s success,” said Leslie Trigg, chair and CEO. “We are pleased to achieve this important milestone and remain vigilant as we work to continuously improve everything we do on behalf of the patients and providers we serve.”
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