Tag Archives: FDA

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analyzing the FDA’s finalized guidance on dose optimization for oncology products, which was released a year after the draft guidance.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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Femtech company Clue, known for its app focused on menstrual cycle tracking and reproductive health, has announced a new partnership with digital mental health provider Headspace. Through this collaboration, members of Clue Plus, Clue’s subscription service, will receive a 50% discount on Headspace subscriptions. This partnership aims to enhance the mental health and mindfulness support […]

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Pfizer and BioNTech are currently developing a combination mRNA vaccine targeting both COVID-19 and influenza, which has shown mixed outcomes in a key clinical trial. The study’s results met only one of the two primary objectives for demonstrating the vaccine’s ability to initiate an immune response, according to an announcement made by the companies on […]

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Expansion of Medical AI Technologies in Asia: Advancements and Collaborations Highlight In a significant move within the medical technology sector, South Korean company Heuron has announced a new distribution agreement to bring its advanced medical AI solutions to Thailand. This collaboration involves a partnership with Medhealth Informatics, a prominent AI software distributor in Thailand. Together, […]

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Stereotaxis, a company specializing in robotic systems for minimally invasive endovascular procedures, has recently achieved a significant milestone by securing the CE mark for its new robotic surgery system, GenesisX, in Europe. This approval is crucial as it allows the company to introduce its advanced technology to the European market. Additionally, Stereotaxis has submitted a […]

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The digital therapeutics company Big Health has recently achieved an important milestone with the FDA 510(k) clearance for SleepioRx, a digital therapeutic specifically designed to alleviate insomnia and enhance overall sleep quality. This 90-day digital treatment program addresses insomnia by focusing on the cognitive and behavioral aspects that contribute to the disorder, employing a foundation […]

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Globus Medical, a company specializing in musculoskeletal devices, recently received a warning letter from the FDA due to violations found at one of its facilities. The violations were primarily concerned with the company’s management of quality systems and their reporting of medical device-related incidents. These findings were revealed following a February and March inspection of […]

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