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Call for Abstracts: MTI Regulatory Intelligence and Networking Summit

By MedTech Intelligence Staff

The call for abstracts for the 2024 MTI Regulatory Intelligence and Networking Summit, hosted by Medtech Intelligence, is now open. The Summit, which will be held June 3-5, 2024, Washington,…

The call for abstracts for the 2024 MTI Regulatory Intelligence and Networking Summit, hosted by Medtech Intelligence, is now open. The Summit, which will be held June 3-5, 2024, Washington,…

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FDA Announces New Genetic Metabolic Advisory Committee

By MedTech Intelligence Staff

The FDA is creating a new advisory committee related to potential treatments for genetic metabolic diseases. The Genetic Metabolic Diseases Advisory Committee will advise the agency on products used for…

The FDA is creating a new advisory committee related to potential treatments for genetic metabolic diseases. The Genetic Metabolic Diseases Advisory Committee will advise the agency on products used for…

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Bob Tilling, Kallik
Soapbox

From TikTok Trends To Counterfeit Drugs: How Better Labeling Systems Can Help

By Bob Tilling

news from traditional news sources, so they may be more susceptible to unregulated content. Behind this content are health and fitness influencers who are all-too-often unqualified and unlicensed, potentially spreading…

news from traditional news sources, so they may be more susceptible to unregulated content. Behind this content are health and fitness influencers who are all-too-often unqualified and unlicensed, potentially spreading…

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Naomi Schwartz

Medcrypt Appoints Former FDA Officer to Vice President of Services

Naomi Schwartz, former premarket reviewer and consumer safety officer for the FDA, has been promoted to serve as Vice President of Services at Medcrypt, a cybersecurity solution provider for medical…

Naomi Schwartz, former premarket reviewer and consumer safety officer for the FDA, has been promoted to serve as Vice President of Services at Medcrypt, a cybersecurity solution provider for medical…

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FDA Withdraws from Global Harmonization Working Party

By MedTech Intelligence Staff

On November 27, the FDA announced its withdrawal as a member of the Global Harmonization Working Party (GHWP), which the agency joined in December 2021. The FDA stated that it…

On November 27, the FDA announced its withdrawal as a member of the Global Harmonization Working Party (GHWP), which the agency joined in December 2021. The FDA stated that it…

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FDA Publishes Final Guidance on Assessing Credibility of CM&S in Device Submissions

By MedTech Intelligence Staff

The FDA has published its final guidance Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. The final guidance provides a framework that manufacturers can use to…

The FDA has published its final guidance Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. The final guidance provides a framework that manufacturers can use to…

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FDA Recognizes AAMI SW96 Cybersecurity Guidance Document

By MedTech Intelligence Staff

The FDA has officially extended complete recognition to the Association for the Advancement of Medical Instrumentation (AAMI) guidance document on medical device cybersecurity, ANSI/AAMI SW96. Per the FDA, ANSI/AAMI SW96:2023,…

The FDA has officially extended complete recognition to the Association for the Advancement of Medical Instrumentation (AAMI) guidance document on medical device cybersecurity, ANSI/AAMI SW96. Per the FDA, ANSI/AAMI SW96:2023,…

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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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Megan Coder

Bringing Digital Health Products to the Global Market

By MedTech Intelligence Staff

…and efficacy side, but there is a lot to be figured out in terms of what is good and sufficient. Subscribe to the MedTech Intelligence weekly newsletter to stay up…

…and efficacy side, but there is a lot to be figured out in terms of what is good and sufficient. Subscribe to the MedTech Intelligence weekly newsletter to stay up…

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Joseph Carson

Access Management Strategies: Best Practices and Emerging Trends for Cybersecurity Teams

By Joseph Carson

…example, accessing data at unusual times or viewing confidential content—the system perceives it as a potential security breach. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date…

…example, accessing data at unusual times or viewing confidential content—the system perceives it as a potential security breach. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date…

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