Tag Archives: Compliance

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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Philips has initiated a recall for several models of its Sense XL Torso coils utilized in MRI machines due to the potential for these devices to overheat, posing a risk of burns to patients during MRI scans. The recall impacts six models of the Sense XL Torso coils that are compatible with both 1.5T and […]

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Pulse Biosciences has announced a significant shift in its regulatory strategy for the Cellfx cardiac clamp, a pulsed field ablation (PFA) device initially being guided through the 510(k) pathway for clearance. The company initially filed for 510(k) clearance in January, but after the Food and Drug Administration (FDA) requested human data, Pulse has now decided […]

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In the growing field of healthcare technology, artificial intelligence (AI) is increasingly being integrated into solutions aimed at enhancing the clinical experience. While some applications of AI in healthcare, like ambient AI scribes, are widely accepted for reducing administrative duties and increasing clinician-patient interaction time, many AI iterations fall into a less controlled area likened […]

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In the world of medical device manufacturing, the primary goal is to deliver safe, effective, and pertinent solutions to healthcare problems. A recurring challenge, however, arises when a device meets its specified requirements but fails to address the actual needs of its intended users. This disconnect emphasizes the critical need for accurately defining user needs […]

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Eli Lilly, a major player in the pharmaceutical industry, is taking strides toward offering more convenient treatment options for patients with inflammatory diseases through the development of pill-based therapies. The company’s latest move in this direction is the $3.2 billion acquisition of Morphic Therapeutic, a deal that adds a promising oral small molecule drug candidate […]

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The European Medicines Agency (EMA) has recently approved Dupixent, a drug developed by Sanofi and Regeneron Pharmaceuticals, as the first biologic therapy for adults with uncontrolled chronic obstructive pulmonary disorder (COPD) characterized by elevated blood levels of eosinophils, a type of white blood cell. This marks a significant development in the treatment for COPD, particularly […]

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