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…
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…
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,…
…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…
…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…
…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…
…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…
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…
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…
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…
