Tag Archives: Compliance

Embecta, a notable company in the medical device sector, recently announced receiving 510(k) clearance from the Food and Drug Administration (FDA) for its first insulin patch pump. This device is specifically designed for individuals diagnosed with either Type 1 or Type 2 diabetes and is capable of being worn for up to three days per […]

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Premarket Approval (PMA) is the most demanding regulatory process in the United States for Class III medical devices, which are considered high-risk. These devices might be crucial for sustaining life, important for preventing significant health impairments, permanently implanted, or present a high degree of risk and potential for fatality. The FDA requires substantial clinical data […]

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As Labor Day approaches, marking the end of summer, many students are gearing up for the new school year, a period often fraught with concerns for children with food allergies. This year, however, brings a fresh development: the FDA’s recent approval of the first epinephrine nasal spray, neffy, by ARS Pharma. This alternative to the […]

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In a significant shift within the medtech sector, particularly in diabetes care, major players are forming alliances that were once considered unlikely, as fierce competitors turn into collaborative partners. Traditionally known for its proprietary nature, the medical device industry, especially in diabetes care technology, is now witnessing a major transformation towards openness and integration. The […]

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I’m sorry for any inconvenience, but based on the text provided, there isn’t enough content to create an 800-word summary. The provided excerpt is only a brief introduction to an article about the FDA finalizing its first guidance on the Voluntary Malfunction Summary Report (VMSR) program for medical devices seven years after its inception. It […]

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I’m sorry, but I cannot provide a summary of the full article as the content beyond the introduction is not provided in your request. However, from the introduction given, it can be summarized as follows: The FDA’s Center for Devices and Radiological Health (CDRH) plans to host a meeting of its Patient Engagement Advisory Committee […]

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The Food and Drug Administration (FDA) has released finalized guidance for its Voluntary Malfunction Summary Reporting (VMSR) program aimed at medical device manufacturers. Initiated in 2018, the VMSR program allows participating manufacturers to report certain device malfunctions in a summarized quarterly format, rather than providing individual reports every 30 days. This approach was designed to […]

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The Association for Molecular Pathology (AMP) has initiated a legal battle against the Food and Drug Administration (FDA) by filing a lawsuit in the U.S. District Court for the Southern District of Texas. The suit challenges a newly finalized rule by the FDA that extends its regulatory oversight over laboratory developed tests (LDTs). AMP, which […]

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As the mpox outbreak continues to escalate in Africa, the U.S. Food and Drug Administration (FDA) has granted approval to Emergent BioSolutions’ vaccine, ACAM2000, aiming to prevent infection from the virus. This approval is a significant move by the FDA and might pave the way for further authorizations as the vaccine is considered by other […]

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Digital musculoskeletal care provider Hinge Health has joined forces with virtual care specialist Midi Health to create a novel partnership aimed at enhancing care for women experiencing menopausal symptoms. The collaboration is set to integrate Hinge Health’s movement-based therapies with Midi Health’s extensive virtual clinic services to form a comprehensive treatment approach for menopause and […]

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