Medical Innovation Exchange

Product Design & Development

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

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

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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Medtronic Announces First Patient Treated in Global Collaboration with Cydar Medical

Medtronic Announces First Patient Treated in Global Collaboration with Cydar Medical     Medtronic announced that the first patient in a 40-site global pilot program that brings Cydar Medical’s artificial intelligence (AI) solution, Cydar Maps, into the clinical environment has been treated. Cydar Maps generates a 3D map of patient soft tissue to support and integrate …

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MD PnP Presents Remote Control Care Testing and Verification Method

MD PnP Presents Remote Control Care Testing and Verification Method     At the 2023 Military Health System Research Symposium (MHSRS) in Orlando, Florida, researchers with the Medical Device “Plug-and-Play” Interoperability & Cybersecurity Program (MD PnP) at Massachusetts General Hospital (MGH), presented a poster outlining a systematic testing method for remote device operation that can be used …

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

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 CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity

FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity     The FDA, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is soliciting input on how to enhance clinical study diversity. They will be hosting a two-day virtual public workshop on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging …

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FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity

FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity     The FDA, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is soliciting input on how to enhance clinical study diversity. They will be hosting a two-day virtual public workshop on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging …

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The Underrated Variable of IoMT Device Security: Collaboration

The Underrated Variable of IoMT Device Security: Collaboration     Healthcare delivery organizations face significant operational risks (at best) and dangerous patient outcomes (at worst) if they fail to sufficiently secure internet-connected devices and equipment across their entire lifecycles. To put some rather eye-opening numbers to it: a recent Ponemon Institute survey revealed that more than …

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The Underrated Variable of IoMT Device Security: Collaboration

The Underrated Variable of IoMT Device Security: Collaboration     Healthcare delivery organizations face significant operational risks (at best) and dangerous patient outcomes (at worst) if they fail to sufficiently secure internet-connected devices and equipment across their entire lifecycles. To put some rather eye-opening numbers to it: a recent Ponemon Institute survey revealed that more than …

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Join J&J, Pfizer and FDA at the Supply Chain Summit and Advanced Manufacturing Conference

Join J&J, Pfizer and FDA at the Supply Chain Summit and Advanced Manufacturing Conference     Supply chain challenges and the move to advanced manufacturing are two key issues affecting the Medtech industry. On November 7-9, MedTech Intelligence will be hosting the MedTech Advanced Manufacturing Conference and Supply Chain Summit, in partnership with Axendia, Inc. The …

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