Tag Archives: FDAcopilot

Inspire Medical Systems recently received approval from the Food and Drug Administration (FDA) for its new obstructive sleep apnea (OSA) neurostimulator therapy, named Inspire V. The company announced plans to begin a soft launch of the device by the end of 2024 with a full launch projected for 2025. This news came shortly after Inspire […]

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Daniel Wilson has been named the new CFO of iRhythm Technologies, taking over from Brice Bobzien, who will step down due to personal reasons on August 31, as announced by the company. Bobzien, who joined iRhythm in August 2022 from Dexcom, expressed his decision on an earnings call, with CEO Quentin Blackford showing support and […]

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The development of drugs for autoimmune diseases is challenged by immune responses against biologic therapies. Emerging companies employ innovative techniques, including artificial intelligence and novel biologic drug platforms, to mitigate these risks and develop new treatments. Key advancements and investments in the field of Immunology and Inflammation show the dynamic landscape of biotech: Abiologics launched […]

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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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