Author: FDAcop

Schizophrenia, affecting approximately 2.8 million people in the U.S., has traditionally been managed with medications that often come with severe side effects and limited effectiveness, resulting in poor adherence by patients. Recognizing the need for improved treatments, the Food and Drug Administration (FDA) recently approved Bristol Myers Squibb’s (BMS) new drug, Cobenfy. This approval marks […]

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Healthcare providers are increasingly incorporating AI technologies, with many reporting a boost in their technology spending over the last year. This surge in adoption reflects the enthusiasm and potential seen in AI’s ability to transform various aspects of healthcare. Dr. Arash Harzand, a respected figure in cardiology from Emory University and the chief health officer […]

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Qure.ai, a Mumbai-based company, recently raised $65 million in a Series D funding round led by Lightspeed and 360 ONE Asset. The funds will primarily be used to invest in foundational AI models and acquire complementary startups in the medical technology sector. Additionally, Qure.ai plans to use the financial boost to expand its operations in […]

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The FDA is proposing a significant modification in the classification of hepatitis B virus (HBV) tests, shifting them from a high-risk category (class III) to a moderate-risk category (class II). This change, detailed in a recent notice, would allow these devices to access the 510(k) pathway rather than undergoing the more stringent premarket approval requirements […]

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Two House Democrats, Representatives Anna Eshoo of California and Rosa DeLauro of Connecticut, have called for an official investigation into Jeff Shuren, the former director of the FDA’s Center for Devices and Radiological Health. This request follows a report by The New York Times detailing potential conflicts of interest during Shuren’s tenure. The representatives expressed […]

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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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