Jiang Li
MEDdesign

Making the Most of Medical Wearables: Addressing Patient Adherence Challenges

By Jiang Li, Ph.D.

…researchers should implement strategies such as compliance monitoring and robust data analysis. Continuous or real-time data monitoring is more commonly used in a healthcare setting, especially in acute situations that…

…researchers should implement strategies such as compliance monitoring and robust data analysis. Continuous or real-time data monitoring is more commonly used in a healthcare setting, especially in acute situations that…

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Stefano Vicenzetto

Ask the Expert:  Improving Sustainability in Medical Device Manufacturing

With a growing focus on climate commitment, MedTech companies are examining how their products are repaired, refurbished and recycled. The Health Solutions team at Flex is partnering with them on…

With a growing focus on climate commitment, MedTech companies are examining how their products are repaired, refurbished and recycled. The Health Solutions team at Flex is partnering with them on…

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FDA Logo

FDA Withdraws from Global Harmonization Working Party

By MedTech Intelligence Staff

…on the management committee. Development of documents is driven by regulators. There is a clear and consistent public consultation process to allow for stakeholder engagement. On September 18, 2023, the…

…on the management committee. Development of documents is driven by regulators. There is a clear and consistent public consultation process to allow for stakeholder engagement. On September 18, 2023, the…

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NeuroAccess Cap

Cordance Medical’s NeuroAccess Receives FDA Breakthrough Device Designation

By MedTech Intelligence Staff

The FDA has granted NeuroAccess from Cordance Medical, a medical device company focused on opening the Blood-Brain Barrier (BBB) to facilitate liquid biopsy, Breakthrough Device Designation. The NeuroAccess device is…

The FDA has granted NeuroAccess from Cordance Medical, a medical device company focused on opening the Blood-Brain Barrier (BBB) to facilitate liquid biopsy, Breakthrough Device Designation. The NeuroAccess device is…

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FDA Logo

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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James F. Jordon
Soapbox

Leveraging Gamification and AI: The Future of Mental Health Care

By James F. Jordan

…usher in a new paradigm of empowerment and compassion in mental healthcare.   References: [1] https://www.forbes.com/sites/otsuka/2023/06/26/prescription-digital-therapeutics-are-expanding-what-it-means-to-treat-mental-health/?sh=6372cffd4bcf&gclid=Cj0KCQjwy4KqBhD0ARIsAEbCt6igw5Yxv94PQCfr9OfLSqYBQL_TvrFqsRe_Ci4UxkmKLzJaXxRMs2IaAkztEALw_wcB [2] “‘Why AI-Powered Mental Health Solutions Are Vital.”, Intelliverse.ai, September 28, 2023, https://www.linkedin.com/pulse/why-ai-powered-mental-health-solutions-vital-intelliverse-ai-lab/  …

…usher in a new paradigm of empowerment and compassion in mental healthcare.   References: [1] https://www.forbes.com/sites/otsuka/2023/06/26/prescription-digital-therapeutics-are-expanding-what-it-means-to-treat-mental-health/?sh=6372cffd4bcf&gclid=Cj0KCQjwy4KqBhD0ARIsAEbCt6igw5Yxv94PQCfr9OfLSqYBQL_TvrFqsRe_Ci4UxkmKLzJaXxRMs2IaAkztEALw_wcB [2] “‘Why AI-Powered Mental Health Solutions Are Vital.”, Intelliverse.ai, September 28, 2023, https://www.linkedin.com/pulse/why-ai-powered-mental-health-solutions-vital-intelliverse-ai-lab/  …

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Dhirti Roy

Ask the Expert: Benefits and Challenges of the eStar Submission Process

…eSTAR also accepts combination products and Dual 510(k)/CLIA Waiver IVDs. eSTAR allows submitters to provide comprehensive data for premarket review for various medical devices. Its standardized format helps submitters complete…

…eSTAR also accepts combination products and Dual 510(k)/CLIA Waiver IVDs. eSTAR allows submitters to provide comprehensive data for premarket review for various medical devices. Its standardized format helps submitters complete…

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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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Caroline Shleifer
Soapbox

Unlocking Success in SaMD Product Launches Through AI

By Caroline Shleifer

…it directly impacts the business. As a result, manufacturers can make well-informed decisions about market entry strategies through comprehensive analysis, factoring in regulatory intricacies and commercial potential. Thus, these platforms’…

…it directly impacts the business. As a result, manufacturers can make well-informed decisions about market entry strategies through comprehensive analysis, factoring in regulatory intricacies and commercial potential. Thus, these platforms’…

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