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FDA Updates Guidance on ISO 10993-1 for Evaluation of Biocompatibility  

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FDA Updates Guidance on ISO 10993-1 for Evaluation of Biocompatibility       The FDA has updated its guidance, Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process,” to provide further clarification and updated information on the use of International Standard ISO 10993-1, …

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Successful Development, Approval and Deployment of Digital Health Solutions

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Successful Development, Approval and Deployment of Digital Health Solutions     For life sciences companies seeking to develop, deploy and successfully commercialize digital health products and solutions, the pathway to success can have many twists and turns, and be littered with false starts, roadblocks and more than a few misdirections. The pace of technological development—which is …

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FDA Issues Three New Draft Guidances on the 510(k) Program

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FDA Issues Three New Draft Guidances on the 510(k) Program     On September 6, the FDA published three new draft guidances as part of its efforts to modernize the 510(k) Program with the goal of improving the safety of medical devices while continuing to bring critical devices to patients. The new guidances include: On October …

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HiRO Enters U.S. with Acquisition of CRO Courante Oncology

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HiRO Enters U.S. with Acquisition of CRO Courante Oncology     Harvest Integrated Research Organization (HiRO), a global contract research organization (CRO), has acquired Courante Oncology, a U.S.-based full-service clinical research provider specializing in oncology product development. HiRO is a boutique CRO serving the Asia-Pacific region. Its acquisition of Courante Oncology extends the organization’s presence into the …

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EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose

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EU MDR Annex XVI Introduces New Burdens for Products Without an Intended Medical Purpose     Adopted in 2017, the EU Medical Device Regulation (MDR) brought a host of changes. In its Annex XVI, for example, the regulation expands its scope to take in new product groups referred to as “products without an intended medical purpose”—in …

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UK Releases Draft Post Market Surveillance Requirements for Medical Devices

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UK Releases Draft Post Market Surveillance Requirements for Medical Devices     The UK has released a draft of its proposed Post Market Surveillance Requirements for Medical Devices. If the draft regulations, “The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023,” are approved, they will pertain to devices sold in England, Wales, Scotland and …

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Advanced Solutions to Prevent Undesired Moisture in Pharmaceutical Manufacturing

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Advanced Solutions to Prevent Undesired Moisture in Pharmaceutical Manufacturing     Excess humidity can affect a pharmaceutical’s structure, chemical stability, dissolving rate and more. This unwanted moisture can come in contact with product at multiple points throughout production and shipping. However, modern technologies are making it easier for companies to control humidity levels. Following are seven …

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MRI Safety Testing:  Making Implants More Compatible with Magnetic Resonance Imaging

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MRI Safety Testing:  Making Implants More Compatible with Magnetic Resonance Imaging     Magnetic resonance imaging (MRI) is key when it comes to diagnosing and treating complex injuries or diseases. For spinal injuries or degeneration or different types of cancer there is rarely any better way to diagnose. Problems that may lead to serious conditions can …

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FDA Seeks Input on At-Home Use Medical Technologies

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FDA Seeks Input on At-Home Use Medical Technologies     The FDA Center for Devices and Radiological Health (CDRH) is seeking input from the medical device industry, the public, patient advocacy organizations, healthcare providers and clinical researchers on at-home use medical devices. Expanding access to home use technologies is part of the CDRH’s 2022-2025 Strategic Priority …

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Mitigating Supply Chain Risks

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Mitigating Supply Chain Risks     On November 8-9, members of the Medtech community will gather in Washington, DC, for the MedTech Supply Chain Intelligence Summit. Hear from industry leaders and join in the discussion as we highlight strategies for overcoming current challenges and preparing for future supply chain risks. Learn how your peers assess and …

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