Author: FDAcop

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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The Food and Drug Administration (FDA) has recently granted market authorization to NowDiagnostics for its at-home syphilis blood test, marking a significant development in the realm of medical diagnostics. Known as the First To Know Syphilis Test, this is the first over-the-counter diagnostic tool of its kind, capable of delivering results in just 15 minutes […]

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Medtronic, a leading medical technology company, has demonstrated positive financial results in the first quarter of fiscal year 2025, highlighted by a revenue growth of 2.8% year-over-year, reaching $7.92 billion. This growth is driven by strong performances in various business segments, notably in the cardiovascular and diabetes sectors. The cardiovascular division itself grew by 5.5%, […]

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The U.S. Food and Drug Administration (FDA) continually monitors the safety of drugs and medical devices even after they have been approved and hit the market. This post-market surveillance is crucial for ensuring the ongoing safety and efficacy of these products. To enhance this surveillance, researchers, including members from the FDA’s Center for Drug Evaluation […]

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The Association for Molecular Pathology (AMP), along with University of Texas pathologist Michael Laposata, has initiated a lawsuit against the Food and Drug Administration (FDA). This legal action is a response to the FDA’s decision to regulate lab-developed tests (LDTs), which the AMP argues exceeds the agency’s regulatory authority. This suit, filed in Texas, marks […]

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Cresilon, a Brooklyn-based startup founded in 2010 by Joe Landolina, a first-year student at New York University, has made significant advances in the field of hemostatic products. Since its inception, the company has raised around $130 million in venture capital and expanded its team to over 80 employees. Recently, Cresilon achieved a major milestone by […]

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Grail, a company specializing in cancer detection tests, recently announced a significant restructuring plan which includes laying off about 350 employees, representing 25% of its workforce as of June 30. This decision follows Grail’s separation from Illumina, its former parent company, which occurred less than two months prior. The layoffs are part of a strategic […]

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