Tag Archives: News

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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Unfortunately, the provided text is too brief and lacks sufficient content to create an 800-word summary. The text is an introduction that refers to an article analyzing the FDA’s finalized guidance on dose optimization for oncology products, which was released a year after the draft guidance. The focus of the article is on understanding the […]

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In a recent development, Tandem Diabetes Care has continued to face challenges with its iPhone app linked to the t:slim X2 insulin pump, as some users still report rapid battery depletion issues despite ongoing software updates aimed at resolving the problem. The difficulties persist even after a recall initiated by the company in March and […]

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Abbott and Medtronic, two renowned leaders in the medical device industry, have historically competed in various healthcare markets. However, in a significant move, they have recently announced a collaboration aiming to enhance diabetes care through advanced technological integration. The partnership focuses on developing a novel continuous glucose monitoring (CGM) system by merging Abbott’s FreeStyle Libre […]

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The summary provided below is based on a fictional article conceived within the prompt given and does not refer to actual events or publications. On August 9, Lykos Therapeutics received a Complete Response Letter (CRL) from the FDA regarding its application for the drug midomafetamine (MDMA) aimed at treating post-traumatic stress disorder (PTSD). This decision […]

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