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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Alisa Chestler

Overcoming Barriers to EHR Adoption in Behavioral Health

By MedTech Intelligence Staff

community of providers to know about their mental health issues. While we know that physical health and mental health truly do go together, this is not fully embraced or comprehended…

community of providers to know about their mental health issues. While we know that physical health and mental health truly do go together, this is not fully embraced or comprehended…

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Stu Johnson
Soapbox

The Drivers Boosting Medtech Investments in Cloud-based Digital Transformation

By Stu Johnson

…most pressing concerns, we sponsored the State of Manufacturing Technology survey. This is a free resource that medical device manufacturers can download to benchmark their own businesses and IT strategies…

…most pressing concerns, we sponsored the State of Manufacturing Technology survey. This is a free resource that medical device manufacturers can download to benchmark their own businesses and IT strategies…

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MedTech Regulatory Intelligence Virtual Summit

…provide insight into the current and coming global regulatory landscape and provide strategies and best practices for ensuring compliance.” The event offers two registration options: Individual ($99) or Enterprise License…

…provide insight into the current and coming global regulatory landscape and provide strategies and best practices for ensuring compliance.” The event offers two registration options: Individual ($99) or Enterprise License…

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Sharps disposal
Soapbox

Leveraging IoT in Medical Waste Management

By Wes Sonnier

…standard. However, these methods come with a heavy environmental price tag: Air Pollution: Incineration releases harmful pollutants, including dioxins, furans and mercury, into the atmosphere. These pollutants can lead to…

…standard. However, these methods come with a heavy environmental price tag: Air Pollution: Incineration releases harmful pollutants, including dioxins, furans and mercury, into the atmosphere. These pollutants can lead to…

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