Author: FDAcop

The U.S. Food and Drug Administration (FDA) has recently granted Apple authorization to add a hearing aid feature to its Airpods Pro earbuds. This decision marks Apple as the first company to receive approval for over-the-counter (OTC) hearing aid software, which they applied for through the de novo premarket review pathway. The announcement came shortly […]

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Bicara Therapeutics, a Boston-based company, is developing a novel therapy to address head and neck squamous cell carcinoma (HNSCC), a cancer typically linked to tobacco smoke or human papillomavirus (HPV). The therapy might represent a significant improvement over existing treatments, particularly for recurrent or metastatic HNSCC cases, where an estimated 80% are HPV-negative. These cases […]

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In vitro diagnostics (IVDs) are critical medical devices used worldwide, important for diagnosis and management in various health conditions. These tools extend from routine blood glucose tests to advanced cancer diagnostics and play a vital role in medical decision-making. They operate by analyzing biological samples such as blood or tissue, often using equipment like test […]

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The Food and Drug Administration (FDA) recently authorized Apple AirPods Pro 2 to function as over-the-counter (OTC) hearing aids for individuals with mild to moderate self-perceived hearing loss. This revolutionary step allows users to conduct a clinically-validated hearing test via their iPhone. The results of this test will enable personalized hearing settings specifically tailored for […]

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In an illuminating episode of the Global Medical Device Podcast, hosted by Etienne Nichols, Perry Parendo, a seasoned expert in the Design of Experiments (DOE), takes the spotlight to discuss the impactful role DOE plays in the medical device industry, especially in the fields of research and development (R&D) and manufacturing. This conversation not only […]

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Sanofi is expanding its presence in the pharmaceutical industry by delving into the radiopharmaceutical sector, following the lead of other major pharmaceutical companies. The company has entered a licensing agreement to acquire AlphaMedix, a clinical-stage radiopharmaceutical therapy developed by RadioMedix and Orano Med, targeting a rare type of gastrointestinal cancer. Under the terms of the […]

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Corrective and Preventive Action (CAPA) is a fundamental process required by the FDA under 21 CFR 820.100 for medical device professionals. It serves to correct and prevent systemic issues in the production and management of medical devices. The CAPA requirement entails several key activities: Analysis of Various Data Sources: Medical device manufacturers must analyze data […]

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In recent times, diabetes technology has seen significant advancements, notably in the areas of continuous glucose monitors (CGMs) and insulin pumps. These developments have positioned this sector at the forefront of medical device innovation. A major highlight within the field is the approval and emergence of over-the-counter (OTC) CGMs, which has garnered considerable attention within […]

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Observational studies are experiencing significant shifts that necessitate a transformation in research approaches, particularly due to the arrival of groundbreaking therapies such as CAR-T cell therapies, which require long-term study over decades. Traditional site-based research models, which rely on patients regularly visiting clinical sites, are becoming impractical for such extended periods because of the high […]

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The landscape of medical device innovation is advancing at a rapid pace, challenging existing regulatory and quality assurance systems meant to ensure safety and efficacy. As device functionality and interoperability escalate, traditional methods used in design and production struggle to keep pace, leading to an increase in recalls and stricter regulatory scrutiny. To manage these […]

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