Month: July 2024

In a recent announcement, the Food and Drug Administration (FDA) has raised concerns about disruptions in the supply of BD Bactec blood culture media bottles, highlighting potential impacts on patient diagnosis and subsequent management. Becton Dickinson (BD), the manufacturer of these bottles, acknowledged in June that its customers might face “intermittent delays” in receiving supplies […]

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Over the past two decades, the United States has witnessed a troubling trend in the closure of maternal care centers, predominantly in rural areas, leading to widespread maternal care deserts. Prior to these closures, 45% of rural counties lacked hospital maternity services, a situation that only worsened between 2004 and 2014 when an additional 9% […]

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The recent U.S. Supreme So the grid,options of your land’ looktureCourt decision to overturn the Chevron doctrine could have significant implications for the regulation of Food and Drug Administration (FDA) activities, particularly concerning lab-developed tests (LDTs). The 6-3 ruling in late June scrapped the Chevron deference, a legal principle that required courts to defer to […]

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Novo Nordisk recently faced a setback as the FDA rejected their application for icodec, a diabetes treatment designed for once-weekly dosing instead of daily injections. The FDA’s concerns centered on the manufacturing process and the drug’s application for type 1 diabetes, with specific worries about heightened risks of hypoglycemia. Despite this hitch, icodec continues to […]

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The Food and Drug Administration (FDA) has recently finalized guidance for medical device companies focusing on interventions designed to treat opioid use disorder (OUD). The guidance, which remains relatively consistent with the draft released in July 2024, addresses various clinical considerations for conducting studies and demonstrating the safety and effectiveness of such devices. Notably, no […]

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In a recent development, Johnson & Johnson (J&J) has restricted the use of three specific models of its Megadyne patient return electrodes, which are critical components used during electrosurgery. This decision follows reports that these devices pose a risk of causing burns to patients. In a June recall notice, J&J specified that these reusable electrodes—part […]

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Ipsen, a Paris-based pharmaceutical company, is expanding its presence in the dynamic field of cancer treatment research through a recent agreement with Foreseen Biotechnology. This deal grants Ipsen global rights to Foreseen’s antibody drug conjugate (ADC), FS001, which is anticipated to soon undergo its initial human testing phase. FS001 is especially notable for targeting a […]

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This summary provides an overview of a regulatory struggle that has spanned nearly half a century. Since the 1970s, the industry has been actively lobbying the FDA and Congress to treat medical gases differently from other drug products. After decades of advocacy, a final rule was passed that includes some of the concessions the industry […]

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Recently, the Coalition for Health AI (CHAI), a prominent industry group aiming to create standards for the utilization of artificial intelligence (AI) in healthcare, witnessed the resignations of two key federal government officials from its board of directors. Micky Tripathi, the national coordinator for health information technology, and Troy Tazbaz, director of the digital health […]

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At the recent Galaxy Unpacked event in Paris, Samsung introduced a series of new AI-powered devices aimed at enhancing health and wellness through advanced technology. Among the new offerings are the Galaxy Ring, the Galaxy Watch Ultra, and the updated Galaxy Watch 7. The standout debut was the Galaxy Ring, Samsung’s first foray into health-monitoring […]

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