FAST FIVE: iRhythm’s FDA warning letter, Masimo management and activist investor trade blows

The global release of Exactech's next-generation GPS Shoulder system marks an important milestone in shoulder arthroplasty. The launch, taking place in EMEA and APAC countries, follows the first surgery in the United Arab Emirates earlier this month. Fast Five Hosts Danielle Kirsh and Chris Newmarker share details about the orthopedic device and what doctors think of the system. With a new CE mark, Establishment Labs has completed a full transition of all currently marketed Motiva implants and tools, as well as the company’s quality management systems, to be in compliance with the new European Medical Device Regulation (MDR). Newmarker explains the devices included in the new indication and what surgeons and executives think about it. The FDA’s breakthrough designation for CardioRenal's Tenor at-home blood potassium measuring device signifies a significant advancement in monitoring and managing blood potassium levels in patients. This innovative device enables individuals to conveniently and accurately measure their potassium levels from the comfort of their own homes. Kirsh and Newmarker explain the benefits of at-home monitoring and how Tenor works. The clash between Masimo management and activist investor Politan has brought attention to the strategic direction and governance of the company. With differing perspectives on key decisions and company performance, this dispute highlights the challenges faced by organizations in managing shareholder expectations. Newmarker details the disagreement between the two parties and who on the board of directors is up for a vote. iRhythm’s receipt of an FDA warning letter regarding its Zio AT quality systems highlights the importance of robust quality control measures in the medical device industry. iRhythm’s response to the FDA warning letter and its actions to address the identified issues will be closely watched by regulators. Hear more about the warning letter from the Fast Five hosts.

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