Optical imaging, rice university

Wearable Microscopes Could Eliminate Biopsies and Blood Tests

By MedTech Intelligence Staff

Rice University has received an award from the National Science Foundation that will help researchers develop a platform technology for non-invasive diagnostic testing. The team, comprised of co-investigators from Rice…

Rice University has received an award from the National Science Foundation that will help researchers develop a platform technology for non-invasive diagnostic testing. The team, comprised of co-investigators from Rice…

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Emmanuel Garnier, Simmons & Simmons LLP

Medtech Companies Must Prepare for Brexit Now

By Emmanuel Garnier

Preparing for Brexit is not just a matter for EU and national authorities, but also for private parties, notably life sciences and medtech companies throughout the world. All companies must…

Preparing for Brexit is not just a matter for EU and national authorities, but also for private parties, notably life sciences and medtech companies throughout the world. All companies must…

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

Seriously, No Audits Performed Since 2015?

By Dr. Christopher Joseph Devine

…an inspection; having to worry about the basics (e.g., internal audits) just adds to their angst. Remember, having observation-free inspections, commences with the instauration(look-it-up) of a compliant QMS. Enjoy! Warning…

…an inspection; having to worry about the basics (e.g., internal audits) just adds to their angst. Remember, having observation-free inspections, commences with the instauration(look-it-up) of a compliant QMS. Enjoy! Warning…

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Nathan Muller, StarFish Medical
MEDdesign

Biomaterials: Overview and Design Considerations

By Nathan MĆ¼ller

…biological in origin. Both biologically passive—like titanium or polyesters in heart valves—and bioactive—such as hydroxyapatite-coated bone implants—constitute biomaterials. Some combination products also make use of biomaterials — an example would…

…biological in origin. Both biologically passive—like titanium or polyesters in heart valves—and bioactive—such as hydroxyapatite-coated bone implants—constitute biomaterials. Some combination products also make use of biomaterials — an example would…

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FDA

Report: FDA Removed More Than 2500 Medical Device Establishments from Database

By MedTech Intelligence Staff

In the past month, FDA has removed 2,546 medical device establishments from the agency’s registration database. According to a post on Registrar Corp.’s website, there were 27,124 registered establishments on…

In the past month, FDA has removed 2,546 medical device establishments from the agency’s registration database. According to a post on Registrar Corp.’s website, there were 27,124 registered establishments on…

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Stephanie Domas, MedSec

Medtech Cybersecurity State Not All Doom and Gloom, But Long Way to Go

By Maria Fontanazza

…security tool, they may misbehave because they weren’t anticipating such communication. It’s another very common problem in hospital systems—you cannot use standard security tools to test the security of a…

…security tool, they may misbehave because they weren’t anticipating such communication. It’s another very common problem in hospital systems—you cannot use standard security tools to test the security of a…

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3D printing

Medical 3-D Printing Making Rapid Strides in Asia

By Ames Gross

…Fuwai Hospital, the largest Class III hospital devoted to cardiovascular disease in the Chinese capital. The company aims to use its 3-D printing software to provide clinical planning tools for

…Fuwai Hospital, the largest Class III hospital devoted to cardiovascular disease in the Chinese capital. The company aims to use its 3-D printing software to provide clinical planning tools for

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Laura Osifchin, Gene Nichols

How to Drive Change and Compliance in a Cost-Reduction Environment

By Gene Nichols, Laura Osifchin

…Ashvin, S. (July 2015). Changing Change Management. McKinsey & Company. Retrieved from https://www.mckinsey.com/global-themes/leadership/changing-change-management. What Drives Employee Engagement and Why It Matters. (2012). Dale Carnegie Training White Paper. Retrieved from https://www.dalecarnegie.com/assets/1/7/driveengagement_101612_wp.pdf….

…Ashvin, S. (July 2015). Changing Change Management. McKinsey & Company. Retrieved from https://www.mckinsey.com/global-themes/leadership/changing-change-management. What Drives Employee Engagement and Why It Matters. (2012). Dale Carnegie Training White Paper. Retrieved from https://www.dalecarnegie.com/assets/1/7/driveengagement_101612_wp.pdf….

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Banyan Biomarkers

FDA Allows Marketing of First Blood Test to Assess Mild Traumatic Brain Injury

By MedTech Intelligence Staff

…to its Breakthrough Devices Program. “The FDA’s review team worked closely with the test developer and the U.S. Department of Defense to expedite a blood test for the evaluation of…

…to its Breakthrough Devices Program. “The FDA’s review team worked closely with the test developer and the U.S. Department of Defense to expedite a blood test for the evaluation of…

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

What, No Training?

By Dr. Christopher Joseph Devine

…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (January 2018). Inspections, Compliance, Enforcement, and…

…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (January 2018). Inspections, Compliance, Enforcement, and…

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