Month: July 2024

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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Medical robotics company Clarapath recently secured $36 million in a Series B-1 funding round, led by Northwell Ventures. With this latest injection of capital, the company’s total funding has reached $75 million. New investors included Ochsner Ventures, CU Healthcare Innovation Fund, and Mayo Clinic. Based in New York, Clarapath has developed SectionStar, an autonomous AI-driven […]

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The Food and Drug Administration (FDA) has recently approved Guardant Health’s Shield blood test, marking it as a primary screening tool for colorectal cancer for average-risk adults aged 45 and older. This approval positions the Shield test as a more appealing and convenient alternative to traditional colorectal cancer screening methods, such as colonoscopies and stool-based […]

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Alopecia areata, a condition characterized by sudden hair loss due to the immune system attacking hair follicles, affects both men and women and can involve areas of the body beyond the scalp. Estimates suggest that around 700,000 people in the U.S. suffer from this condition, with 300,000 experiencing what is considered severe alopecia areata. For […]

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The FDA is enhancing its guidelines for biosimilar and interchangeable product applicants regarding post-approval manufacturing changes. The updated draft guidance focuses on new considerations for applicants looking to introduce new dosage forms or strengths, or to produce the product in facilities that also handle different versions of the biological product. This development is aimed at […]

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