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"Biomedical Technology legislation "
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Natural hydrogels R&D process: technical and regulatory aspects for industrial implementation
Since hydrogel therapies have been introduced into clinic treatment procedures, the biomedical industry has to face the technology transfer and the scale-up of the processes. This will be key in the roadmap of the new technology implementation. Transfer technology and scale-up are already known for some applications but other applications, such as 3D printing, are still challenging. Decellularized tissues offer a lot of advantages when compared to other natural gels, for example they display enhanced biological properties, due to their ability to preserve natural molecules. For this reason, even though their use as a source for bioinks represents a challenge for the scale-up process, it is very important to consider the advantages that originate with overcoming this challenge. Therefore, many aspects that influence the scaling of the industrial process should be considered, like the addition of drugs or cells to the hydrogel, also, the gelling process is important to determine the chemical and physical parameters that must be controlled in order to guarantee a successful process. Legal aspects are also crucial when carrying out the scale-up of the process since they determine the industrial implementation success from the regulatory point of view. In this context, the new law Regulation (EU) 2017/745 on biomedical devices will be considered. This review summarizes the different aspects, including the legal ones, that should be considered when scaling up hydrogels of natural origin, in order to balance these different aspects and to optimize the costs in terms of raw materials and engine.
Journal Article
Knee replacement
Knee replacement surgery is one of the most commonly done and cost-effective musculoskeletal surgical procedures. The numbers of cases done continue to grow worldwide, with substantial variation in utilisation rates across regions and countries. The main indication for surgery remains painful knee osteoarthritis with reduced function and quality of life. The threshold for intervention is not well defined, and is influenced by many factors including patient and surgeon preference. Most patients have a very good clinical outcome after knee replacement, but multiple studies have reported that 20% or more of patients do not. So despite excellent long-term survivorship, more work is required to enhance this procedure and development is rightly focused on increasing the proportion of patients who have successful pain relief after surgery. Changing implant design has historically been a target for improving outcome, but there is greater recognition that improvements can be achieved by better implantation methods, avoiding complications, and improving perioperative care for patients, such as enhanced recovery programmes. New technologies are likely to advance future knee replacement care further, but their introduction must be regulated and monitored with greater rigour to ensure patient safety.
Journal Article
Market and Patent Analyses of Wearables in Medicine
Wearable medical devices (WMDs) will advance point-of-care diagnostics and therapeutics. This article analyses the market and patents for wearable devices. Activity monitors have the largest market share, and the intellectual property landscape is dominated by electronics corporations. However, the majority of these patents have not been realized in commercial products.
Journal Article
China’s medical-device industry gets a makeover
The country is keen to boost its production of medical technology to reduce its reliance on imports. Analysts discuss the impact of policies.
The country is keen to boost its production of medical technology to reduce its reliance on imports. Analysts discuss the impact of policies.
Journal Article
Theranos and the scientific community: at the bleeding edge
Elizabeth Holmes, the company's founder and former CEO, once the world's youngest self-made female billionaire, was last week found guilty of four of 11 charges of fraud related to her actions at the now defunct blood testing company. Conscientious scientists at Theranos who voiced concerns—and there were several—were marginalised, fired, and made to sign non-disclosure agreements under the threat of litigation, supposedly in the name of protecting trade secrets. For the Lancet Commission on diagnostics: transforming access to diagnostics see https://www.thelancet.com/commissions/diagnostics For more on automated assays see Articles Lancet Infect Dis 2021; published online Oct 7. https://doi.org/10.1016/S1473-3099(21)00452-7 For more on metabolomics see Clin Cancer Res 2022; published online Jan 4. https://doi.org/10.1158/1078-0432.CCR-21-2855 For more on investment in health care technology see https://www.economist.com/business/how-health-care-is-turning-into-a-consumer-product/21807114 Kimberly White/Getty Images
Journal Article
Digital health technologies in clinical trials for central nervous system drugs: an EU regulatory perspective
Digital health technologies have the potential to help address some of the challenges in the clinical development of drugs for central nervous system disorders. This article discusses strategies for the development of such tools in the context of the European regulatory environment.Digital health technologies have the potential to help address some of the challenges in the clinical development of drugs for central nervous system disorders. This article discusses strategies for the development of such tools in the context of the European regulatory environment.
Journal Article
Holmes verdicts prompt questions over justice for patients
Soon after, the Centers for Medicare & Medicaid Services found that the Theranos laboratory violated federal rules, and the US Food and Drug Administration reclassified the nanotainers—devices that store the droplets of blood—as higher-risk medical devices subject to additional safety requirements. In 2017, Theranos agreed to pay more than 76 000 Arizona customers $4·6 million to settle claims by the Arizona Attorney General that the company's “advertisements misrepresented the method, accuracy, and reliability of its blood testing and that the company was out of compliance with federal regulations contained in the Clinical Laboratory Improvement Amendments of 1988”. In September, 2021, a three-judge panel of the US Court Of Appeals for the Ninth Circuit allowed a class action lawsuit to proceed against Holmes, Balwani, and Walgreens filed by patients in California and Arizona who received Theranos blood tests. [...]with interest rates so low, the only real way to make
Journal Article
The Evolving Regulatory Paradigm of AI in MedTech: A Review of Perspectives and Where We Are Today
Artificial intelligence (AI)-enabled technologies in the MedTech sector hold the promise to transform healthcare delivery by improving access, quality, and outcomes. As the regulatory contours of these technologies are being defined, there is a notable lack of literature on the key stakeholders such as the organizations and interest groups that have a significant input in shaping the regulatory framework. This article explores the perspectives and contributions of these stakeholders in shaping the regulatory paradigm of AI-enabled medical technologies. The formation of an AI regulatory framework requires the convergence of ethical, regulatory, technical, societal, and practical considerations. These multiple perspectives contribute to the various dimensions of an evolving regulatory paradigm. From the global governance guidelines set by the World Health Organization (WHO) to national regulations, the article sheds light not just on these multiple perspectives but also on their interconnectedness in shaping the regulatory landscape of AI.
Journal Article