Asia

Asia Cancer Market Update (2016)

By Ames Gross

…remains low in India and China compared to other Asian countries. Increases in Asian healthcare spending are often times aimed at dealing with cancer, including improving early detection and diagnosis…

…remains low in India and China compared to other Asian countries. Increases in Asian healthcare spending are often times aimed at dealing with cancer, including improving early detection and diagnosis…

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human factors engineering, product development

A Missed Opportunity: Incorporating Human Factors Engineering into Product Development

By Jon Tilliss, Allison Strochlic

…(i.e., validation) usability test of safe and effective device use—usually a prerequisite for approval. In many cases, summative usability testing reveals use errors that might be avoided by making a…

…(i.e., validation) usability test of safe and effective device use—usually a prerequisite for approval. In many cases, summative usability testing reveals use errors that might be avoided by making a…

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Alert

Major Adverse Cardiac Events in Abbottā€™s BVS Triggers FDA Investigation

By MedTech Intelligence Staff

…versus patients treated with the company’s metallic XIENCE drug-eluting stent. Implanted during an angioplasty, the BVS opens coronary arteries that have been blocked by plaque to increase blood flow to…

…versus patients treated with the company’s metallic XIENCE drug-eluting stent. Implanted during an angioplasty, the BVS opens coronary arteries that have been blocked by plaque to increase blood flow to…

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Ameing for Asia

Pollution Chokes Asia, Increases Medtech Opportunities

By Ames Gross

…warnings stating air pollution has reached unhealthy levels. The Medtech Opportunity Medtech companies that can provide products to help patients combat pollution are in high demand. Nebulizers are frequently used…

…warnings stating air pollution has reached unhealthy levels. The Medtech Opportunity Medtech companies that can provide products to help patients combat pollution are in high demand. Nebulizers are frequently used…

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FDA

FDA Releases Proposed List of 510(k) Exempt Class II Devices

By MedTech Intelligence Staff

FDA has compiled a document containing more than 1000 Class II devices that the agency is suggesting be exempt or partially exempt from 510(k) requirements. Listed in the Federal Register,…

FDA has compiled a document containing more than 1000 Class II devices that the agency is suggesting be exempt or partially exempt from 510(k) requirements. Listed in the Federal Register,…

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Michael Lohan, IDA Ireland
Soapbox

Irelandā€™s Medtech Industry Will Benefit from Brexit

By Michael Lohan

…the EU when Brexit is invoked. That business-language advantage is complemented by Ireland’s pro-business environment, competitive corporate tax rate at 12.5%, innovation and skills, as well as its common law…

…the EU when Brexit is invoked. That business-language advantage is complemented by Ireland’s pro-business environment, competitive corporate tax rate at 12.5%, innovation and skills, as well as its common law…

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Cybersecurity, mhealth

Protecting Products in the Face of Cybersecurity Vulnerabilities

By Maria Fontanazza

…doing right when it comes to addressing cybersecurity? Elan: Companies are starting to ask good questions and examine and understand the environment of risk. We are also seeing regulators respond…

…doing right when it comes to addressing cybersecurity? Elan: Companies are starting to ask good questions and examine and understand the environment of risk. We are also seeing regulators respond…

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

Training, Training, and More Training

By Dr. Christopher Joseph Devine

…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Denttio, Inc.Accessed March 7, 2017. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm543694.htm….

…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Denttio, Inc.Accessed March 7, 2017. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm543694.htm….

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Scott Gottlieb, FDA

President Trump to Pick Scott Gottlieb as FDA Commish

By MedTech Intelligence Staff

President Trump will reportedly nominate Scott Gottlieb, M.D. to serve as the next FDA commissioner. Gottlieb served as deputy commissioner for medical and scientific affairs during the George W. Bush…

President Trump will reportedly nominate Scott Gottlieb, M.D. to serve as the next FDA commissioner. Gottlieb served as deputy commissioner for medical and scientific affairs during the George W. Bush…

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Global Regulatory Strategy

Top Tips for Your Global Regulatory Strategy

By Maria Fontanazza

…portfolio (know which products to phase out and which to move forward with). – Peter Havel, TUV SUD On best practices and leadership skills “Communication. I don’t think you can…

…portfolio (know which products to phase out and which to move forward with). – Peter Havel, TUV SUD On best practices and leadership skills “Communication. I don’t think you can…

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