Medical Innovation Exchange

01-Digital Health

Creating a Connected Ecosystem: Challenges and Opportunities

Creating a Connected Ecosystem: Challenges and Opportunities     The landscape of healthcare is evolving, driven by a myriad of factors such as workforce shortages, chronic disease prevalence, and supply chain issues. In response to these challenges, healthcare organizations are increasingly turning to digital capabilities to navigate the complexities of the modern world. Digital transformation has …

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AI’s Ability to Detect Tumor Cells Could be Key to More Accurate Bone Cancer Prognoses

AI’s Ability to Detect Tumor Cells Could be Key to More Accurate Bone Cancer Prognoses     Press Release: MTI Staff was not involved in writing this content April 2, 2023 / Kyushu, Fukuoka, Japan – Researchers at Kyushu University have developed and validated a machine-learning model that can accurately evaluate the density of surviving tumor …

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FDA Outlines its Approach to Artificial Intelligence Regulation

FDA Outlines its Approach to Artificial Intelligence Regulation     U.S. regulation of artificial intelligence (AI) in medical devices will involve cooperative work among multiple departments within the FDA. On March 15, the FDA released “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” which outlines how the agency’s medical product …

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Mayo researchers invented a new class of AI to improve cancer research and treatments

Mayo researchers invented a new class of AI to improve cancer research and treatments     Press Release: MTI Staff was not involved in writing this content March 11, 2024 /Mayo Clinic News Network/ — Mayo Clinic researchers recently invented a new class of artificial intelligence (AI) algorithms called hypothesis-driven AI that are a significant departure …

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Bringing MedTech Innovation to Life

Bringing MedTech Innovation to Life     Technological advancement in MedTech is enabling faster and more accurate diagnoses and treatments for patients around the world. From wearables to AI-powered innovation, medical technology has opened the door to more personalized and real-time care.Our society’s aging global population, coupled with the rise in chronic diseases among younger populations, …

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FDA Issues New Draft Guidance on Premarket Cybersecurity Considerations

FDA Issues New Draft Guidance on Premarket Cybersecurity Considerations     On March 12, the FDA issued the draft guidance “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.” Which includes select updates to the FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (aka, Premarket Cybersecurity …

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Designing Compliant Wireless Medical Devices

Designing Compliant Wireless Medical Devices     Wireless medical devices make patient care safer and more efficient. They eliminate tripping hazards that may endanger both medical staff and patients. Secondly, the digital connection of various devices elevates monitoring and diagnostics to a higher level, significantly enhancing reliability in surgery and other medical areas. Wireless medical devices …

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NIST Releases Updated Cybersecurity Framework

NIST Releases Updated Cybersecurity Framework     The National Institute of Standards and Technology (NIST) has updated its Cybersecurity Framework (CSF) guidance document for reducing cybersecurity risk. The new 2.0 edition, which supports implementation of the National Cybersecurity Strategy, has an expanded scope that goes beyond protecting critical infrastructure, such as hospitals and power plants, to …

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AI Oversight of Growing Interest to Health Care Executives

AI Oversight of Growing Interest to Health Care Executives      Artificial intelligence (AI) is drawing greater interest from health systems looking to reduce the burden of documentation on clinicians and add automation to administrative functions, among other potential benefits. Yet, very few health systems have written formal policies addressing the use of AI and even …

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FDA-Cleared SaMD by the Numbers

FDA-Cleared SaMD by the Numbers     If industry buzz is any measure of actual activity, then Software as a Medical Device (SaMD) is the current darling of the MedTech world. Despite this, it’s difficult to quantify just how many SaMD have reached the market in the U.S. While the information needed to identify a medical …

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