Month: July 2024

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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Truvian Health, a company specializing in blood-testing technology, recently announced that it has raised $74 million in funding, securing partnerships with notable entities such as Shoppers Drug Mart, Canada’s largest pharmacy chain. The funding round was co-led by Great Point Ventures and Wittington Ventures, with additional contributions from existing investors like Medical Excellence Capital, Tao […]

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For patients suffering from gout, a painful form of arthritis caused by excess uric acid in the blood, conventional treatments may not always provide relief. In such cases, Amgen’s biologic drug has been a potential alternative, yet its effectiveness is often limited by the immune system which might recognize the therapeutic protein as foreign, initiating […]

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Getting a medical device to market is a complex journey involving design, development, and meticulous adherence to regulatory requirements. A top-tier quality management system (QMS) like Greenlight Guru Quality is crucial for pre-market MedTech companies, providing essential tools to manage documentation, secure necessary approvals, and maintain a compliant, traceable system. Greenlight Guru has been instrumental […]

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Data management and reporting are pivotal aspects of conducting FDA-regulated clinical trials for medical devices. Ensuring the precision, security of clinical data, and adherence to Good Clinical Practice (GCP) are vital for the success of your study and subsequent regulatory submissions to the FDA. This article offers a detailed guide on the FDA’s guidance and […]

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