Tag Archives: FDAgpt

The content provided is a brief announcement regarding significant organizational and policy changes in U.S. health technology management, specifically within the Department of Health and Human Services (HHS). The news announced includes the creation of a new Assistant Secretary for Technology Policy position within the HHS, showcasing an elevation of responsibilities previously managed by an […]

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Biocompatibility testing is essential for ensuring that medical devices do not cause adverse biological responses when they come into direct or indirect contact with the human body. This type of testing is crucial because it helps to prevent potential harmful effects such as skin irritation, systemic illnesses like cancer, and other serious health issues arising […]

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Kevin Strange has been appointed as the new Chief Financial Officer (CFO) of Inari Medical, slated to begin his new role in early October. This announcement was made by Inari Medical, a company known for its clot removal devices, coinciding with the disclosure of their second-quarter earnings. Strange will be succeeding Mitch Hill, who has […]

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For manufacturers of Class III high-risk medical devices, gathering clinical investigation data is crucial for successful regulatory approval in the United States. The U.S. Food and Drug Administration (FDA) mandates Premarket Approval (PMA) for these products, heavily relying on clinical data to assess device safety and effectiveness. Setting up and conducting a compliant clinical trial […]

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In a significant legal move, Philips has initiated a lawsuit against PSN Labs, holding them accountable for what it considers critical errors in the risk analysis of soundproofing foam used in its sleep apnea devices. Filed in the U.S. District Court for the Western District of Pennsylvania, Philips contends that the inaccurate conclusions drawn by […]

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Cell therapies, originally developed for treating blood cancers, have marked a significant advancement in cancer treatment. Adaptimmune Therapeutics has notably contributed to this field with the recent FDA approval of its product for synovial sarcoma, a rare cancer that affects soft tissues like muscles and ligaments, primarily in males under 30. This approval of Tecelra […]

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Design controls are essential quality practices and procedures mandated for medical device companies under 21 CFR Part 820 and ISO 13485:2016. These controls guarantee that medical devices satisfy their intended uses, user needs, and specified requirements. By integrating design controls into the broader Quality Management System (QMS), companies ensure that the risk of future device […]

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Huma, initially established in 2011 as a patient monitoring software company, has evolved significantly, particularly during the COVID-19 pandemic when its Medopad technology was used by the U.K.’s National Health Service to monitor COVID-19 patients remotely. Currently, in 2024, Huma is making strides towards revolutionizing healthcare digitization, evidenced by their recent announcement of raising $80 […]

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Axena Health, known for its innovative digital therapeutic solutions for women’s pelvic health, has collaborated with telehealth company UpScriptHealth to enhance the accessibility and convenience of consultations and treatments for women experiencing urinary incontinence. This partnership allows women to benefit from UpScriptHealth’s direct-to-consumer telehealth services, helping them address symptoms of urinary incontinence effectively. The key […]

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The Food and Drug Administration (FDA) recently issued a warning to Amco International Manufacturing & Design, a producer of batteries for Automated External Defibrillators (AEDs) used in devices distributed by prominent companies like Philips, Stryker, and Zoll. This warning stemmed from Amco’s continued distribution of these batteries without obtaining the required premarket approval (PMA), a […]

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