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Successful Development, Approval and Deployment of Digital Health Solutions

Leave a Comment / Compliance Management, connected care, Digital Health, end user, Focus Article, Health Data, interoperability, Manufacturing Execution, Medical Device, MedTech, Quality/Regulatory, RC - Device Design & Manufacturing, regulatory compliance, software design / By

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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Revolutionizing Healthcare: Augmented Reality’s Unprecedented Impact

Leave a Comment / AI, AI/ML, aurgmented reality, Care Coordination, Care Delivery, Digital Health, healthcare delivery, Medical Device, MedTech, RC - Device Design & Manufacturing, Soapbox / By

Revolutionizing Healthcare: Augmented Reality’s Unprecedented Impact     The landscape of healthcare has undergone an evolution in recent years, driven by the integration of augmented reality (AR) technology into medical practices. AR, with the help of artificial intelligence (AI), is providing healthcare professionals with the means to offer patients an unprecedented level of care and personalized …

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Reshaping of the Biotech M&A Landscape

Leave a Comment / biotech, Digital Health, Focus Article, Medical Device, MedTech, MedTech Economics, mergers and acquisitions, orphan drugs, patents / By

Reshaping of the Biotech M&A Landscape     The biotechnology industry has always been marked by innovation, rapid technological advancements and a drive to prevent, treat and cure disease. The prospect of mergers, acquisitions and joint collaboration deals with larger pharmaceutical giants has always served as fuel for the aspirations of small and mid-sized biotechnology companies. …

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Get Well Achieves FedRAMP Authorized Designation

Leave a Comment / cloud platforms, Digital Health, Market Access, Medical Device, MedTech, patient engagement / By

Get Well Achieves FedRAMP Authorized Designation     Get Well, a provider of enterprise digital patient experience and navigation solutions for hospitals and communities, announced that it has achieved Federal Risk and Authorization Management Program (FedRAMP) authority to operate (ATO) at the Moderate security impact level for its cross-continuum digital patient engagement platform. FedRAMP is a …

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Medtronic Announces First Patient Treated in Global Collaboration with Cydar Medical

Leave a Comment / AI, Digital Health, endovascular, imaging, Medical Device, MedTech, Product Design & Development / By

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

Leave a Comment / Digital Health, interoperability, MD PnP, MEDdesign, Medical Device, MedTech, Product Design & Development, RC - Device Design & Manufacturing, remote control, remote critical care / By

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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FDA Seeks Input on At-Home Use Medical Technologies

Leave a Comment / Digital Health, health equity, home use devices, Medical Device, MedTech, patient access, Quality/Regulatory, RC - Medtech Regulatory Resource Center / By

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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Final Guidance for Submission of Off-The-Shelf Software in Medical Devices

Leave a Comment / compliance, Digital Health, Final Guidance, Medical Device, MedTech, off the shelf software, premarket approval, Quality/Regulatory, RC - Medtech Regulatory Resource Center / By

Final Guidance for Submission of Off-The-Shelf Software in Medical Devices     On August 11, the FDA released the Final Guidance Off-the-Shelf Software Use in Medical Devices. The document, which supersedes Off-The-Shelf Software Use in Medical Devices issued September 27, 2019, provides information on recommended documentation sponsors should include in a premarket submission for FDA’s evaluation …

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Bringing More Patients Home

Leave a Comment / Digital Health, hospital at home, Medical Device, MedTech, poast surgical care, Quality/Regulatory, remote patient monitoring, sepsis recovery, wearables / By

Bringing More Patients Home     Overcrowded emergency departments, a lack of hospital beds and skyrocketing healthcare costs are among the challenges facing the U.S. healthcare system. The ability to provide hospital-level care to select patients at home through the use of new technologies and in-home nursing visits provided temporary relief during the pandemic, and may …

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The Underrated Variable of IoMT Device Security: Collaboration

Leave a Comment / collaboration, connected devices, cybersecurity, Digital Health, HDOs, IoMT, Medical Device, MedTech, patches, patient safety, Product Design & Development, RC - Device Design & Manufacturing, RC - Medical Device Audits, Certification & Verification / By

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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