Cliff Weinstein, FLI Charge
Soapbox

The Future of Power in Healthcare Facilities

By Cliff Weinstein

competitive advantage for facilities when it comes to elective medical procedures. Monitoring & Recording Patient Data As health records move to be stored digitally, the data gathered by medical devices…

competitive advantage for facilities when it comes to elective medical procedures. Monitoring & Recording Patient Data As health records move to be stored digitally, the data gathered by medical devices…

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Asia

Expanding Hospital Markets in Asia Provides Opportunities for MedTech Manufacturers: The Hospital Market in China (Part I)

By Ames Gross

…is focused on increasing its healthcare spending in the coming years. China’s per-capita spending on healthcare stood at $367 in 2015, compared to $9,416 in the United States. That leaves…

…is focused on increasing its healthcare spending in the coming years. China’s per-capita spending on healthcare stood at $367 in 2015, compared to $9,416 in the United States. That leaves…

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Anura Fernando, UL
MEDdesign

Beyond Cybersecurity

By Anura Fernando

…with chronic health conditions? The folks at my company have been pondering such socially relevant questions since the dawn of the commercialization of electricity and the associated unintended consequences of…

…with chronic health conditions? The folks at my company have been pondering such socially relevant questions since the dawn of the commercialization of electricity and the associated unintended consequences of…

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FDA

FDAā€™s Voluntary Malfunction Summary Reporting Program to Reduce Number of MDRs

By MedTech Intelligence Staff

Today FDA announced it has finalized the Voluntary Malfunction Summary Program, the goal of which is to streamline the way in which malfunctions are reported while still giving the agency…

Today FDA announced it has finalized the Voluntary Malfunction Summary Program, the goal of which is to streamline the way in which malfunctions are reported while still giving the agency…

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Chen Kuan, Infervision
Soapbox

Let AI Do What It Does Best: Help Doctors

By Chen Kuan

…intelligence through continuous machine learning. AI deployment in the industry has been highly encouraging. Side-by-side comparisons are demonstrating the value of AI as an assistant to radiologists. A recent competition…

…intelligence through continuous machine learning. AI deployment in the industry has been highly encouraging. Side-by-side comparisons are demonstrating the value of AI as an assistant to radiologists. A recent competition…

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Doreen McKeown, Enterprise Ireland

Ireland: The Future of MedTech Innovation

By Doreen McKeown

In this data-driven world of cloud connectivity, computing and the Internet of Things, medical companies and healthcare providers are placing a greater emphasis on products and services that can utilize…

In this data-driven world of cloud connectivity, computing and the Internet of Things, medical companies and healthcare providers are placing a greater emphasis on products and services that can utilize…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

What, No Risk Analysis?

By Dr. Christopher Joseph Devine

…quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (July 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Anigan, Inc. Accessed August 06, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm615066.htm…

…quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (July 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Anigan, Inc. Accessed August 06, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm615066.htm…

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Ames Gross, Pacific Bridge Medical
Ameing for Asia

Cutting-Edge Atrial Fibrillation Devices Revitalize Japanese Market

By Ames Gross

…the market in various forms for decades. What is revolutionizing the market for the devices in Japan is the growing presence of the increasingly popular magnetic resonance imaging (MRI)-compatible variety….

…the market in various forms for decades. What is revolutionizing the market for the devices in Japan is the growing presence of the increasingly popular magnetic resonance imaging (MRI)-compatible variety….

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Exome sequencing

Research Activities for Next Generation Sequencing Accelerate, New Studies Outline Efficacy on Treating Fatal Conditions

By Pratik Kirve

…Time Sequencing, Other Technologies) – Global Opportunity Analysis and Industry Forecast, 2014-2022. Retrieved from https://www.alliedmarketresearch.com/next-generation-sequencing-market Zhu M-L, Zhou L, Sadri N. (June 21, 2018), Comparison of targeted next generation sequencing…

…Time Sequencing, Other Technologies) – Global Opportunity Analysis and Industry Forecast, 2014-2022. Retrieved from https://www.alliedmarketresearch.com/next-generation-sequencing-market Zhu M-L, Zhou L, Sadri N. (June 21, 2018), Comparison of targeted next generation sequencing…

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Dollar, money

FY 2019 Medical Device User Fees Increase 4%

By MedTech Intelligence Staff

…Panel-track supplement 241,610 60,403 180-day supplement 48,322 12,081 Real-time supplement 22,550 5,638 BLA efficacy supplement 322,147 80,537 Annual report 11,275 2,819 30-day notice 5,154 2,577 All companies, regardless of size,…

…Panel-track supplement 241,610 60,403 180-day supplement 48,322 12,081 Real-time supplement 22,550 5,638 BLA efficacy supplement 322,147 80,537 Annual report 11,275 2,819 30-day notice 5,154 2,577 All companies, regardless of size,…

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