Category: Artificial Intelligence

The Food and Drug Administration (FDA) has appointed Ross Segan as the new director of the Office of Product Evaluation and Quality (OPEQ) within the Center for Devices and Radiological Health (CDRH). This decision follows a nationwide search for a suitable candidate, as disclosed by an FDA spokesperson. OPEQ is responsible for the premarket review […]

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Biohaven has been persevering with the development of troriluzole, a drug aimed at treating the rare neurodegenerative disorder spinocerebellar ataxia (SCA), despite a series of clinical trials and regulatory setbacks. This persistence seems poised to pay off as the company approaches a new drug application, leveraging a novel approach using real-world data to satisfy regulatory […]

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The Food and Drug Administration (FDA) has released a new draft guidance aimed at improving the biocompatibility assessments of medical devices. This guidance was published in response to consistent inadequacies the FDA has observed within premarket submissions, which seem to stem from lab-to-lab variability in analytical chemistry methods. This inconsistency in report outcomes has prompted […]

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Stryker Corporation has enhanced its portfolio by acquiring Nico Corporation, marking its fourth takeover in recent months. This acquisition brings into Stryker’s fold Nico’s advanced minimally invasive solutions geared toward brain tumor removal and stroke care. Nico has developed an array of devices designed for navigating and visualizing the brain, excising tumors and clots, and […]

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Insilico Medicine, a company that leverages artificial intelligence (AI) technology for drug discovery, has developed a drug candidate named ISM001-055 aimed at treating idiopathic pulmonary fibrosis (IPF), a chronic lung disorder that causes irreversible scarring and declines in lung function. The disease, affecting around 5 million people worldwide, primarily older adults, sees a median survival […]

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The pressing issue of Post-Traumatic Stress Disorder (PTSD) in the United States, affecting 13 million citizens including a substantial number of women and veterans, highlights a critical area of concern in healthcare. PTSD, triggered by traumatic experiences ranging from assault to natural disasters, has shown that current standard-of-care therapies are insufficient for many, with approximately […]

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Dr. Eve Cunningham, Chief of Virtual Care and Digital Health at Providence, highlighted several pressing issues faced by health professionals today during her interview at the INVEST Digital Health conference. As an OB-GYN specialist, she discussed the overwhelming nature of the Electronic Medical Record (EMR) system. Originally, patient charts comprised a mere folder with a […]

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Heart disease has been the top cause of mortality in the United States for over a century, despite significant advancements in understanding and treating this complex condition. Although there are numerous treatment options available that can minimize the risk of severe cardiovascular incidents such as heart attacks or strokes, there is a persistent issue with […]

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Organon is expanding its presence in the dermatology sector through an acquisition of Dermavant, a subsidiary of Roivant Sciences, primarily focusing on a commercialized plaque psoriasis treatment that may soon be applicable to atopic dermatitis, a more common inflammatory skin condition. Organon’s deal could total up to $1.2 billion, with an upfront payment of $175 […]

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Zevra Therapeutics recently received FDA approval for its drug Miplyffa, marking a significant development as it becomes the first approved therapy for Niemann-Pick disease type C (NPC), a severe and often fatal metabolic disorder. This approval is particularly impactful as NPC, a rare inherited condition, affects the central nervous system and can lead to death […]

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