FDA Endoscope Guidance

Dirty Endoscopes: FDA Outlines Risks of Cross Contamination for Device Components

By MedTech Intelligence Staff

…can mitigate the risk. Specifically of interest are the components—the irrigation valves and accessories—that are used with the endoscopes. Clinicians many times use a water bottle to provide irrigation during…

…can mitigate the risk. Specifically of interest are the components—the irrigation valves and accessories—that are used with the endoscopes. Clinicians many times use a water bottle to provide irrigation during…

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Eye Care Needs Rising Quickly in Asia

By Ames Gross

…The company’s sales in Asia grew by more than 50% during the second half of 2015. In light of the CFDA approval of its new laser devices, the company expects…

…The company’s sales in Asia grew by more than 50% during the second half of 2015. In light of the CFDA approval of its new laser devices, the company expects…

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

‘No’ Means No

By Dr. Christopher Joseph Devine

…Yes, tactful coming from Dr. D is a difficult concept to comprehend, considering Dr. D is still a United States Marine at heart. As the doctor’s family is always quick…

…Yes, tactful coming from Dr. D is a difficult concept to comprehend, considering Dr. D is still a United States Marine at heart. As the doctor’s family is always quick…

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MEDICAL, moble medical app

MEDICA’s Medical Mobile App Competition Winners Announced

By MedTech Intelligence Staff

This week at MEDICA several innovative healthcare companies went head-to-head in the hopes of taking home a financial award, along with industry recognition for their mobile medical apps. Review the…

This week at MEDICA several innovative healthcare companies went head-to-head in the hopes of taking home a financial award, along with industry recognition for their mobile medical apps. Review the…

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Bayer, Womens Health

Labeling Changes to Bayer’s Essure Device Include Boxed Warning

By MedTech Intelligence Staff

Following a series of complaints about the safety of Bayer Healthcare’s Essure permanent birth control device, FDA has approved key changes to the product labeling, which is intended to help…

Following a series of complaints about the safety of Bayer Healthcare’s Essure permanent birth control device, FDA has approved key changes to the product labeling, which is intended to help…

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How to Evaluate Attractiveness of Product Ideas and Markets Before Development

By Karl-Hubertus Gruber, Michael Marquardt, Ph.D., ďťżLaszlo Horwitz

…and Contents of a Pre-Analysis In order to complete each step, the pre-analysis process combines primary qualitative and quantitative research (e.g., market expert interviews) with secondary sources (e.g., scientific literature,…

…and Contents of a Pre-Analysis In order to complete each step, the pre-analysis process combines primary qualitative and quantitative research (e.g., market expert interviews) with secondary sources (e.g., scientific literature,…

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FDA neurological devices

FDA Launches New Resource for Neurological Devices

By MedTech Intelligence Staff

FDA has launched a new website aimed at helping bring neurological medical devices to the U.S. market. The website is part of the agency’s support of the White House BRAIN…

FDA has launched a new website aimed at helping bring neurological medical devices to the U.S. market. The website is part of the agency’s support of the White House BRAIN…

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

Who’s on First?

By Dr. Christopher Joseph Devine

…relies heavily on their contract manufacturer and consultants. In fact, virtual companies are nothing new. Regardless, the FDA demands that sufficient structure be in place to support the QMS. That…

…relies heavily on their contract manufacturer and consultants. In fact, virtual companies are nothing new. Regardless, the FDA demands that sufficient structure be in place to support the QMS. That…

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Ameing for Asia

Staying Competitive Amid Rapid R&D Growth in Asia

By Ames Gross

…the top 11 medtech companies have research centers in Asia with more than 250,000 employees. Western companies that perform R&D in Asia still have significant intellectual property risks. It is…

…the top 11 medtech companies have research centers in Asia with more than 250,000 employees. Western companies that perform R&D in Asia still have significant intellectual property risks. It is…

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