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

…2018.” 21 CFR, Part 820.30(g) – Design Controls “(g) Design validation. Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined…

…2018.” 21 CFR, Part 820.30(g) – Design Controls “(g) Design validation. Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined…

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Ames Gross, Pacific Bridge Medical
Ameing for Asia

Cutting-Edge Atrial Fibrillation Devices Revitalize Japanese Market

By Ames Gross

…Unlike traditional pacemakers, MRI-compatible pacemakers have built-in safeguards to block magnetic and radio waves emitted during magnetic resonance imaging. The new pacemaker devices allow patients to undergo MR imaging exams…

…Unlike traditional pacemakers, MRI-compatible pacemakers have built-in safeguards to block magnetic and radio waves emitted during magnetic resonance imaging. The new pacemaker devices allow patients to undergo MR imaging exams…

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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

…of $30 million or less, the company is eligible for a fee waiver for its first PMA, PDP, PMR or biologics license application. FY 2019 User Fees for Medical Device…

…of $30 million or less, the company is eligible for a fee waiver for its first PMA, PDP, PMR or biologics license application. FY 2019 User Fees for Medical Device…

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Stick to Skin Adhesive, 3M

Avoiding a Sticky Situation: Importance of Selecting the Optimal Adhesive for Your Medical Device Design Project

By Del R. Lawson, Ph.D., Tony Kaufman

…of reasons, adhesives are capable of causing manufacturing complications. Why? Here are two common reasons: The adhesive is too soft. If too soft of an adhesive is used, it can…

…of reasons, adhesives are capable of causing manufacturing complications. Why? Here are two common reasons: The adhesive is too soft. If too soft of an adhesive is used, it can…

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Daniel R. Matlis, Axendia
MEDdesign

Stop Validating Computer Systems to Death!

By Daniel R. Matlis

…Age… On May 15, 21 years after the start of the CSV (computer systems validation) cold war, FDA and industry metaphorically declared that it is time to stop validating computer…

…Age… On May 15, 21 years after the start of the CSV (computer systems validation) cold war, FDA and industry metaphorically declared that it is time to stop validating computer…

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gavel

Just Before Summer Recess, House Votes to Repeal Device Tax

By Maria Fontanazza

…you’re going to reduce healthcare costs. And guess what? The device tax caused the loss of over 29,000 jobs.” While the tax was suspended Paulsen noted that medtech companies reinvested…

…you’re going to reduce healthcare costs. And guess what? The device tax caused the loss of over 29,000 jobs.” While the tax was suspended Paulsen noted that medtech companies reinvested…

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Bryan Brosseau, Brosseau Consulting

EU MDR Supplier Quality Requirements: Convergence of Best Practice and Regulation

By Bryan Brosseau

…requirements for any third party involved in the design, manufacture, inspection or testing of the product or any components used therein. The organization must determine the methods and extent of…

…requirements for any third party involved in the design, manufacture, inspection or testing of the product or any components used therein. The organization must determine the methods and extent of…

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