Month: September 2024

Vertex Pharmaceuticals, which transformed the treatment landscape for cystic fibrosis (CF) by creating medicines that now cover 90% of CF patients, is advancing its mission under the leadership of CEO Reshma Kewalramani. Initially, Vertex developed a drug catering to a mere 4% of CF patients; however, their extensive portfolio now encompasses multiple blockbuster drugs and […]

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The Food and Drug Administration (FDA) has recently implemented comprehensive regulations aimed at enhancing the cybersecurity of medical devices, amidst ongoing cyber threats targeting hospitals. Despite these efforts, a significant challenge persists with legacy medical devices that use outdated software, creating vulnerabilities within hospital networks. These devices, although not usually the direct targets of cyberattacks, […]

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In an enlightening episode of the Global Medical Device Podcast, hosted by Etienne Nichols, Leo Eisner, also known as the “IEC 60601 Guy” and the founder of Eisner Safety Consultants, delves into the critical role of standards in medical device development. Leo Eisner has cultivated a significant reputation in the industry for his expertise in […]

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Route 92 Medical, a company specializing in neurovascular intervention products, has recently secured an additional $50 million investment. This latest funding boost is part of an extended November financing round that has brought the company’s total capital raised to $82 million. The funds are earmarked for the global commercialization of their products and to aid […]

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Researchers have identified serious gaps in the clinical testing of heart devices subject to Class I recalls, as detailed in a study published in the Annals of Internal Medicine. Class I recalls are assigned by the Food and Drug Administration (FDA) to situations where there is a reasonable probability that device use will cause serious […]

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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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