Whitehouse 2021

PresidentĀ Biden Issues Executive Order on Artificial Intelligence

By MedTech Intelligence Staff

AI. Promoting Innovation and Competition The Executive Order seeks to ensure that the U.S. continue to lead the way in innovation and competition through the following actions: Catalyze AI research…

AI. Promoting Innovation and Competition The Executive Order seeks to ensure that the U.S. continue to lead the way in innovation and competition through the following actions: Catalyze AI research…

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Puzzle piece

Drivers and Implications of Multi-Billion Dollar Acquisitions in Medtech

By Laurie Halloran, Maria Shepherd

…6). Stryker ponies up $3B to buy Vocera and amp up its digital communications. Fierce Biotech. https://www.fiercebiotech.com/medtech/stryker-lands-3b-deal-for-vocera-to-amp-up-its-digital-communications [3] Stryker announces definitive agreement to acquire Vocera Communications. (2022, January 6). https://investors.stryker.com/press-releases/news-details/2022/Stryker-announces-definitive-agreement-to-acquire-Vocera-Communications/default.aspx…

…6). Stryker ponies up $3B to buy Vocera and amp up its digital communications. Fierce Biotech. https://www.fiercebiotech.com/medtech/stryker-lands-3b-deal-for-vocera-to-amp-up-its-digital-communications [3] Stryker announces definitive agreement to acquire Vocera Communications. (2022, January 6). https://investors.stryker.com/press-releases/news-details/2022/Stryker-announces-definitive-agreement-to-acquire-Vocera-Communications/default.aspx…

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FDA Logo

FDA, MHRA and Health Canada Jointly Publish Guiding Principles for Predetermined Change Control Plans for ML-Enabled Medical Devices

By MedTech Intelligence Staff

…Guiding Principles consider specifically the best practices for PCCPs for AI/ML-enabled medical devices, these principles may be helpful to consider for the application of PCCPs more broadly,” said Tazbaz.  …

…Guiding Principles consider specifically the best practices for PCCPs for AI/ML-enabled medical devices, these principles may be helpful to consider for the application of PCCPs more broadly,” said Tazbaz.  …

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Warren Lesack

EU MDR: Ensuring Labeling Compliance

By Warren Lesack

…a safe market, leaving companies with no alternative but to comply. Compliance is Possible Compliance with EU MDR’s new labeling requirements is no easy feat. Spreadsheets, error-prone legacy systems and…

…a safe market, leaving companies with no alternative but to comply. Compliance is Possible Compliance with EU MDR’s new labeling requirements is no easy feat. Spreadsheets, error-prone legacy systems and…

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Megan Coder

Bringing Digital Health Products to the Global Market

By MedTech Intelligence Staff

…identifying where best practices and commonalities may be, and then helping companies and manufacturers align on what those building blocks should be to create a strong foundation for approval and…

…identifying where best practices and commonalities may be, and then helping companies and manufacturers align on what those building blocks should be to create a strong foundation for approval and…

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Doug Donahue

Ask the Expert: Four Key Reasons Medical Device Manufacturers Should Be Looking at Mexico

…with this growth potential comes increased competition and a need to find ways to become more efficient and cost-competitive, without compromising quality. Mexico offers the ideal, proximate solution, particularly for

…with this growth potential comes increased competition and a need to find ways to become more efficient and cost-competitive, without compromising quality. Mexico offers the ideal, proximate solution, particularly for

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Roger Lam
Soapbox

5 Ways to Maximize the Security of Edge Medical Devices

By Roger Lam

component supplier has not shipped third-party or black-market goods? Do they use components from trusted vendors that provide timely firmware updates, have an in-house engineering team that tracks those updates,…

component supplier has not shipped third-party or black-market goods? Do they use components from trusted vendors that provide timely firmware updates, have an in-house engineering team that tracks those updates,…

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