Tag Archives: FDAcopilot

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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The Food and Drug Administration (FDA) is in the process of establishing an active postmarket surveillance system to enhance the safety monitoring of medical devices. This initiative follows a federal mandate from 2012 that requires improved tracking and oversight of medical devices after they are introduced to the market. The move aims to utilize real-world […]

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Regeneron Pharmaceuticals, a player in the pharmaceutical industry, faces a delay in joining the market of new multiple myeloma treatments due to a recent FDA rejection. The refusal to approve Regeneron’s drug candidate, linvoseltamab, was not based on issues with the drug itself but rather concerns regarding the third-party manufacturer responsible for its production. This […]

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Salcit Technologies, an India-based respiratory healthcare company, has recently partnered with the Google Research team to leverage Google’s Health Acoustic Representations (HeAR) technology in expanding the capabilities of their own bioacoustic AI technology, Swaasa. Swaasa utilizes HeAR to enhance research and improve the early detection of tuberculosis through analyzing cough sounds. This collaboration highlights the […]

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Edwards Lifesciences has recently acquired the transcatheter aortic valve replacement (TAVR) system from Genesis Medtech, specifically targeting severe aortic regurgitation treatment through their J-Valve system. This acquisition includes the purchase of the JC Medical business segment from Genesis, encompassing the intellectual property and commercial rights associated with the J-Valve system. Although the exact sale price […]

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