Tag Archives: News

In response to the recent declaration by the World Health Organization (WHO) classifying the mpox outbreak as a public health emergency of international concern, Roche has announced its commitment to enhance laboratory capacities globally for mpox testing. This announcement came as the new strain of mpox, identified as clade 1b, emerges rapidly in the Democratic […]

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Eli Lilly’s clinical trial for its metabolic disorder drug, tirzepatide, has released promising preliminary results that underscore the medication’s potential in delaying the onset of type 2 diabetes in patients who are obese or overweight. This trial, the longest to date involving tirzepatide, also aimed at assessing its effectiveness in weight management among prediabetes participants. […]

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In recent years, GLP-1-based agonists (GLP-1s) have dramatically altered the landscape of obesity treatment, revealing substantial benefits beyond simple weight loss. Originally introduced about two decades ago as treatments for type 2 diabetes, researchers quickly noted that GLP-1s also facilitated significant weight loss. This serendipitous discovery led to the FDA approval of the first GLP-1 […]

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GLP-1 receptor agonist drugs have revolutionized the pharmaceutical landscape, particularly in the fields of Type 2 diabetes management and weight loss. Brands like Ozempic, Wegovy, Saxenda, Mounjaro, and Zepbound have been key players in reshaping treatment paradigms. Since the FDA’s 2021 approval of Wegovy for weight management, the use of these drugs has skyrocketed, with […]

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Courtney Lias has taken on the role of the permanent Director of the Office of Health Technology 7 (OHT7) at the Center for Devices and Radiological Health (CDRH), following her tenure as Acting Director after Tim Stenzel’s departure at the end of 2023. Lias officially announced her new position during a conference in Washington D.C. […]

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MAUI, an ultrasound imaging company based in Arizona, recently announced its emergence from stealth mode, coinciding with the securing of a substantial $4 million contract from the Department of Defense (U.S. Army Medical Research and Development Command). This contract is focused on incorporating MAUI’s autonomous ultrasound technology, known as the MAUI K3900, into the trauma […]

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In the medical device industry, precision and clarity in communication are crucial due to the high stakes involved in terms of patient safety and regulatory compliance. Misunderstandings can lead to errors that may have serious ramifications, highlighting the importance of a thorough understanding of industry-specific terminology and acronyms. To assist professionals in navigating the complex […]

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The Food and Drug Administration (FDA) has been defending Jeff Shuren, the former director of the agency’s medical device center, following a report by The New York Times. The report discussed potential conflicts of interest arising from Shuren’s professional role at the FDA and his wife Allison Shuren’s position as a legal counsel for medical […]

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Sepsis, a condition often more dangerous than heart attacks and strokes combined, is among the most deadly, costly, and complex challenges hospitals face today. Ajay Shah, the CEO of Cytovale, a medical diagnostics company based in San Francisco, emphasized the severity of sepsis and the critical need for rapid identification and treatment. In light of […]

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Procept Biorobotics has recently received 510(k) clearance from the FDA for Hydros, their updated surgical robot designed for prostate procedures. This marks a considerable advancement from their first-generation device, the Aquabeam, which received de novo authorization in 2017 and has been utilized in roughly 400 hospitals, performing 50,000 procedures to date. The original Aquabeam robot […]

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