Summary The FDA issued an early alert concerning Calyxo’s CVAC aspiration system following a reported death. The issue arises with patients possessing thick kidney fluid, causing reduced outflow and potentially fatal pressure buildup. Calyxo has […]
Summary Smiths Medical has recalled implantable ports due to a manufacturing defect, posing risks such as therapy interruption and air embolism. The company also issued a warning about undersized endotracheal tubes, potentially causing inadequate ventilation. […]
Summary The FDA mandates Guillain-Barré Syndrome warnings for RSV vaccines Abrysvo and Arexvy. Post-marketing data revealed a potential increased risk of GBS within 42 days of vaccination, though a causal link remains unestablished. The FDA […]
Summary Johnson & Johnson is investing $55 billion in US manufacturing, R&D, and technology over the next four years. This investment includes three new manufacturing facilities and the expansion of existing sites, creating thousands of […]
Summary Cardiac Dimensions secures $53M to finalize a U.S. pivotal study and commercialize its groundbreaking Carillon Mitral Contour System. This minimally invasive device offers a novel approach to treating functional mitral regurgitation (FMR) in heart […]
Summary The FDA accuses Mid-Link Technology Testing, a Chinese testing service provider, of falsifying or copying medical device test data. This follows a warning letter issued last year and raises concerns about the integrity of […]
Summary Laplace Interventional secures $22M in Series C funding to advance its minimally invasive tricuspid valve replacement technology. This funding will propel the completion of their Early Feasibility Study and pave the way for a […]
Summary The FDA has added hemodialysis devices to its shortage list, anticipating the scarcity to persist until fall 2025. This shortage stems from supplier disruptions, notably at B. Braun, impacting the availability of essential bloodlines. […]
Summary The EPA is reevaluating emission standards for medical device sterilizers, balancing public health with the need for sterilized equipment. This reconsideration comes as sterilization technology advances, impacting both the environment and healthcare practices. The […]
Summary Labcorp is acquiring BioReference Health’s oncology and oncology-related clinical testing assets for $225 million. This acquisition expands Labcorp’s cancer diagnostic portfolio and strengthens its position in the growing oncology market. The deal is expected […]
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