Tag Archives: Compliance

I’m sorry for any confusion, but the text you’ve provided seems to be an introductory snippet or a description of an article rather than the full article itself. It mentions that the FDA issued a final rule in April 2024 to update regulations regarding Laboratory Developed Tests (LDTs) and notes potential impacts from Supreme Court […]

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The Food and Drug Administration (FDA) has increased its scrutiny of plastic syringes manufactured in China, issuing additional warnings to two companies, Jiangsu Shenli Medical Production and Jiangsu Caina Medical, for failing to meet quality standards. Jiangsu Shenli, which had previously received a warning in March, was sent another warning following a later inspection of […]

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Jeffrey Shuren, a key figure in the regulation of medical devices at the U.S. Food and Drug Administration (FDA), recently announced his decision to step down from his position, ending a tenure of 28 years at the agency. Shuren, who began his career at the FDA in 1998 within the Commissioner’s Office, later ascended to […]

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Over the past decade, significant strides have been made in the understanding and treatment of food allergies. This evolution was significantly highlighted through Dr. Kari Nadeau’s pioneering clinical trials at Stanford University with 85 food allergy patients, published by the New York Times 11 years ago. Dr. Nadeau’s work has paved the way for groundbreaking […]

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The Food and Drug Administration (FDA) uses the “breakthrough” designation to fast-track the development and review of drugs and devices aimed at treating severe conditions, with potential improvements over existing therapies. Despite similar development processes involving significant investment and clinical trials, breakthrough devices face a notably less predictable and longer path to reimbursement compared to […]

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Sun Life, an organization focused on employee and government benefits, has recently partnered with Hinge Health to enhance its musculoskeletal (MSK) care offerings through digital solutions. This collaboration will give Sun Life members specialized access to a range of Hinge Health’s services, including health coaching, orthopedic surgery consultations, physical therapy, and technology like surgery decision […]

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Embecta, a company known for manufacturing insulin syringes and pen needles, is reportedly exploring the possibility of a sale, according to a late report by the Financial Times. Established in Parsippany, New Jersey, Embecta was a division of BD until it became an independent entity in 2022. The company is also in the process of […]

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In the evolving landscape of clinical research, the prioritization of inclusion, innovation, and scalability has become essential for developing treatments that are not only safe and effective but also cater to diverse populations globally. Through leveraging advancements in data and technology, the industry is forging pathways toward more accessible, transformative, and efficient clinical trials. Inclusion […]

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Artiva Biotherapeutics, a biotech company specializing in innovative cell therapy, has successfully raised $167 million through its initial public offering (IPO), aimed at supporting the clinical trials for their novel treatment approaches for autoimmune diseases. Initially pricing the IPO at $12 per share, which fell below the expected price range of $14 to $16 per […]

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Recent developments in AI within the healthcare sector have shown considerable progress since 2021, featuring advancements in the use and commonality of technologies such as Chat GPT by OpenAI and generative AI. Hospitals are exploring AI applications in areas like medical coding, while health tech and medtech companies are broadening the scope of AI integrations […]

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