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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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Stryker Corporation has demonstrated robust financial and operational performance in its most recent quarterly report, showcasing a dynamic push in both its technologies and market expansion strategies. In the second quarter, the company reported revenue of $5.42 billion, marking an 8.5% increase from the previous year. The net income also showed a healthy growth, amounting […]

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Health Canada has approved the t:slim X2 Insulin Pump from Tandem Diabetes Care for sale. This device is designed to be compatible with Dexcom’s G7 and G6 continuous glucose monitoring (CGM) systems. The t:slim X2 features a color touchscreen and can hold up to 300 units of insulin. It incorporates a rechargeable battery with a […]

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Food and Drug Administration (FDA) officials have recently delved into the potential of lifecycle management to tackle the unique challenges posed by generative artificial intelligence (AI) in the healthcare sector. In a detailed blog post published by the FDA’s Digital Health Center of Excellence (DHCoE), the agency’s leaders discuss their ongoing efforts to thoroughly map […]

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Over four years since the initial outbreak, COVID-19 remains a significant health issue, leading to substantial hospitalizations and deaths despite no longer defining daily life for many. Almost 20% of U.S. adults endure long-term symptoms ascribed to Long COVID, highlighting the ongoing impact of the pandemic. Despite the immense benefits of vaccines during the pandemic, […]

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During a session aimed at enhancing home healthcare for diabetes patients, Arianna Gehan, co-founder and CEO of Daia Diabetes, described the daily challenges of managing her Type 1 diabetes, emphasizing the overwhelming experience of alarm fatigue from numerous notifications on her insulin pump and continuous glucose monitor. This session was part of the Food and […]

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In the realm of clinical trials, innovation is a critical necessity to expedite drug development. However, the slow evolution of U.S. clinical trials systems, due in part to resource limitations at the U.S. Food and Drug Administration (FDA), has dulled the pace of critical advancements needed in this sector. Traditionally reliant on pharmaceutical companies to […]

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