Month: July 2024

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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Immunology and inflammation biotechnology company Alumis has recently entered the public markets, securing $250 million in pivotal funding to advance clinical trials of its leading drug candidate. The company aims to demonstrate the efficacy of its small molecule in treating plaque psoriasis, a competitive area currently targeted by several pharmaceutical giants. Alumis’ entry into Nasdaq […]

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AbbVie, a major pharmaceutical company already noted for its leadership in the inflammatory bowel disease (IBD) market with several blockbuster drugs, is further expanding its IBD offerings through strategic acquisitions and development of new drug candidates. Recently, AbbVie has reinforced its commitment to advancing IBD treatment by completing the acquisition of Celsius Therapeutics for $250 […]

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The U.S. Supreme Court has recently issued a series of significant decisions affecting various aspects of healthcare regulation and access. These decisions address the Chevron deference, access to the abortion pill mifepristone, and emergency abortion procedures in Idaho, reflecting the judiciary’s pivotal role in shaping healthcare policy. Chevron Deference Overturned A landmark decision by the […]

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In today’s BioPharmaceutical manufacturing landscape, the necessity for robust data integrity is paramount, as emphasized by the FDA’s Good Manufacturing Practices (GMP) regulations. These guidelines stress the need for precise and reliable data throughout supply chains, yet achieving this high standard can often be underestimated, especially when drug sponsors collaborate with manufacturing partners. Organizations must […]

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