Dr. Abtin Rad

New Cybersecurity Standards for Medical Applications

By Dr. Abtin Rad

…their products for compliance with the new standard and the state of the art today will be on the safe side tomorrow, and fit for the future. Reference: [1] blogs.cisco.com/healthcare/fda-announces-first-ever-recall-of-a-medical-device-due-to-cyber-risk…

…their products for compliance with the new standard and the state of the art today will be on the safe side tomorrow, and fit for the future. Reference: [1] blogs.cisco.com/healthcare/fda-announces-first-ever-recall-of-a-medical-device-due-to-cyber-risk…

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Andrew Mackinnon

Connecting More Patients to Clinical Trials

By Andrew Mackinnon

…for better patient oversight by providing site partners with an accessible, secure, and comprehensive view of a patient’s health during a trial, allowing more timely management of task completion, remote…

…for better patient oversight by providing site partners with an accessible, secure, and comprehensive view of a patient’s health during a trial, allowing more timely management of task completion, remote…

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Thomas Skogen
Soapbox

Risk Management Is More Than a Spreadsheet

By Thomas Skogen

…makes risk management processes increasingly difficult to perform. It is the way medical device companies are handling their processes today. Challenges of Paper-based Processes Many companies are working with manual…

…makes risk management processes increasingly difficult to perform. It is the way medical device companies are handling their processes today. Challenges of Paper-based Processes Many companies are working with manual…

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Emily Newton, Revolutionized Magazine

How MedTech Is Helping the Hearing Impaired

…restoring the ability to process sound, companies are also seeking new ways to help those with hearing loss communicate. Google’s AI team is currently working on products to translate spoken…

…restoring the ability to process sound, companies are also seeking new ways to help those with hearing loss communicate. Google’s AI team is currently working on products to translate spoken…

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FDA Logo

FDA Highlights Exemptions for Real World Data-identified AEs

By MedTech Intelligence Staff

…request is for the modification of a previously granted, currently active exemption A complete statement of the request for exemption, variance, or alternative reporting An explanation of why your request…

…request is for the modification of a previously granted, currently active exemption A complete statement of the request for exemption, variance, or alternative reporting An explanation of why your request…

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Costas Tsougarakis

Laying the Groundwork for an AI Breakthrough

By Costas Tsougarakis

…digital transformations, MedTech companies must look holistically at their data management systems and standards, and create strategies to de-silo data, improve discoverability, and better facilitate the sophisticated level of data…

…digital transformations, MedTech companies must look holistically at their data management systems and standards, and create strategies to de-silo data, improve discoverability, and better facilitate the sophisticated level of data…

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FDA Logo

FDA Issues Draft Guidances on Human Factors and VMSR for Medical Devices

…is intended to be used to complement the FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices” when finalized. “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers” proposes…

…is intended to be used to complement the FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices” when finalized. “Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers” proposes…

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European Union Flag

EU MDR: MDCG Proposes Extended Timeline for Legacy Device Compliance

By MedTech Intelligence Staff

The position paper from the European Commission’s Medical Device Coordination Group (MDCG) recommends an extended timeline to allow certain MDD or AIMDD certified legacy devices to come into compliance with…

The position paper from the European Commission’s Medical Device Coordination Group (MDCG) recommends an extended timeline to allow certain MDD or AIMDD certified legacy devices to come into compliance with…

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Veranex and Fusion logos

Veranex Acquires Fusion Biotec

By MedTech Intelligence Staff

…end-to-end diagnostic instrumentation. The acquisition expands Veranex’s footprint for product design engineering services across the U.S., with combined company offices now in the Eastern, Central, and Western regions, as well…

…end-to-end diagnostic instrumentation. The acquisition expands Veranex’s footprint for product design engineering services across the U.S., with combined company offices now in the Eastern, Central, and Western regions, as well…

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