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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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Renée Bailey

Instructional Materials: The Basis for Safety Between Users and Medical Devices

By Renée Bailey

…device resulting in harm to a user or patient. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device…

…device resulting in harm to a user or patient. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device…

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FDA Updates Breakthrough Devices Program Guidance

By MedTech Intelligence Staff

The FDA has issued an update to the final guidance: Breakthrough Devices Program. The updates are intended to clarify how the Breakthrough Devices Program applies to certain innovative medical devices…

The FDA has issued an update to the final guidance: Breakthrough Devices Program. The updates are intended to clarify how the Breakthrough Devices Program applies to certain innovative medical devices…

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HiRO Enters U.S. with Acquisition of CRO Courante Oncology

Harvest Integrated Research Organization (HiRO), a global contract research organization (CRO), has acquired Courante Oncology, a U.S.-based full-service clinical research provider specializing in oncology product development. HiRO is a boutique…

Harvest Integrated Research Organization (HiRO), a global contract research organization (CRO), has acquired Courante Oncology, a U.S.-based full-service clinical research provider specializing in oncology product development. HiRO is a boutique…

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Get Well Achieves FedRAMP Authorized Designation

By MedTech Intelligence Staff

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…

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…

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UK Releases Draft Post Market Surveillance Requirements for Medical Devices

By MedTech Intelligence Staff

The UK has released a draft of its proposed Post Market Surveillance Requirements for Medical Devices. If the draft regulations, “The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations…

The UK has released a draft of its proposed Post Market Surveillance Requirements for Medical Devices. If the draft regulations, “The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations…

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