Author: FDAcop

Connected health technology company Withings has achieved an exciting milestone by obtaining FDA 510(k) clearance for its innovative Sleep Rx Mat, a device specifically engineered to facilitate the home-based diagnosis of sleep apnea without direct contact with the body. The Sleep Rx Mat employs an advanced pneumatic sensor that meticulously tracks a wide range of […]

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As medical devices increasingly incorporate network connections, the significance of cybersecurity in the healthcare sector is escalating. These devices often store or transmit sensitive patient data, making them targets for cyber threats that could compromise data integrity and patient privacy. Consequently, regulatory bodies worldwide have been developing stringent standards to ensure the safety and security […]

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SS Innovations International is progressing towards securing pre-market authorization in the U.S. for its surgical robotic system, the SSi Mantra, by the end of 2025. This optimistic projection follows a pre-submission meeting with the Food and Drug Administration (FDA), as stated by the company in a recent announcement. Planning to use the FDA’s de novo […]

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Biologic drugs, traditionally administered via lengthy infusions, are now seeing revolutionary advancements with the FDA’s approval of injectable forms that drastically reduce treatment duration. Roche has successfully transformed two of its biologics into injectable versions, one targeting multiple sclerosis (MS) and the other, cancer, thus reducing patient dosing time from hours to minutes. The newly […]

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Inflammatix, a molecular diagnostics company based in Sunnyvale, California, has recently secured $57 million in funding. This financial boost aims to support the regulatory filing and early commercialization of its innovative rapid blood test for diagnosing acute infections and sepsis. The announcement, made on Thursday, increases the company’s total private capital to over $200 million, […]

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Amy Abernethy, a veteran healthcare leader with significant experience at institutions like the FDA and Verily, is championing the acceleration of clinical evidence generation to advance personalized treatment in the healthcare sector. In a recent interview, she emphasized the critical importance of clinical trials and real-world evidence in understanding effective treatments for patients, depending on […]

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If your company manufactures class II or III medical devices registered with the FDA, it’s crucial to prepare for routine FDA inspections. These inspections aim to ensure compliance with regulatory requirements, and regardless of your past inspection experiences, readiness plays a crucial role in determining how smoothly they proceed. Here are detailed actions and recommendations […]

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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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