Medical Innovation Exchange

Digital Health

MaryAnne Rizk Joins Blue Spark Technologies Board of Advisors

MaryAnne Rizk Joins Blue Spark Technologies Board of Advisors     Blue Spark Technologies, a digital health company specializing in AI-powered remote patient monitoring (RPM) to support precision drug development, has appointed MaryAnne Rizk, Ph.D., a leader in drug development technological innovation, to its advisory board. Dr. Rizk will work with Blue Spark Technologies to identify …

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FDA Seeks Members for New Digital Health Advisory Committee

FDA Seeks Members for New Digital Health Advisory Committee     The FDA is seeking subject matter experts to join its new Digital Health Advisory Committee. The role of the committee will be to support safe and effective regulation of digital health technologies while encouraging innovation, and to solicit views from technical and scientific subject matter …

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Successful Development, Approval and Deployment of Digital Health Solutions

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

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

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

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

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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FDA Seeks Input on At-Home Use Medical Technologies

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

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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