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

Big Butts, Take Three!

By Dr. Christopher Joseph Devine

…a serious note, people really do need to exercise some level of common sense when it comes to medicine. Elective medical procedures such as “buttocks injections” should occur in a…

…a serious note, people really do need to exercise some level of common sense when it comes to medicine. Elective medical procedures such as “buttocks injections” should occur in a…

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Asia

Expanding Hospital Markets in Asia Provides Opportunities for MedTech Manufacturers: The Hospital Markets in India and Southeast Asia (Part II)

By Ames Gross

…the 2011–2012 year. Indian healthcare is provided through primary-, secondary- and tertiary-care hospitals. The government manages the first two categories, while tertiary facilities are owned and managed by either the…

…the 2011–2012 year. Indian healthcare is provided through primary-, secondary- and tertiary-care hospitals. The government manages the first two categories, while tertiary facilities are owned and managed by either the…

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FDA

FDA Issues Draft Guidance on Considerations of Uncertainty in Making Benefit-Risk Determinations for Premarket Decisions

By MedTech Intelligence Staff

This week FDA issued a draft guidance to further clarify the considerations related to uncertainty in benefit-risk determinations that support premarket decisions for medical devices. The draft, “Consideration of Uncertainty…

This week FDA issued a draft guidance to further clarify the considerations related to uncertainty in benefit-risk determinations that support premarket decisions for medical devices. The draft, “Consideration of Uncertainty…

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Theranos

ā€œWe Are Now Out of Timeā€: Theranos to Dissolve

By MedTech Intelligence Staff

…letter to company stockholders. He went on to state that the company is in default and owes at least $60 million to its unsecured creditors. The company has already started…

…letter to company stockholders. He went on to state that the company is in default and owes at least $60 million to its unsecured creditors. The company has already started…

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MedTech Intelligence

Top MedTech Summer Stories

By MedTech Intelligence Staff

…Transition Period https://medtechintelligence.com/column/new-mdr-one-year-into-the-transition-period/ 4. Simplifying Medical Device Labeling in a Complex Environment https://medtechintelligence.com/feature_article/simplifying-medical-device-labeling-in-a-complex-environment/ 3. EU MDR Supplier Quality Requirements: Convergence of Best Practice and Regulation https://medtechintelligence.com/column/eu-mdr-supplier-quality-requirements-convergence-of-best-practice-and-regulation/ Learn more about this…

…Transition Period https://medtechintelligence.com/column/new-mdr-one-year-into-the-transition-period/ 4. Simplifying Medical Device Labeling in a Complex Environment https://medtechintelligence.com/feature_article/simplifying-medical-device-labeling-in-a-complex-environment/ 3. EU MDR Supplier Quality Requirements: Convergence of Best Practice and Regulation https://medtechintelligence.com/column/eu-mdr-supplier-quality-requirements-convergence-of-best-practice-and-regulation/ Learn more about this…

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Alcon

Alcon Voluntarily Withdraws CyPass Micro-Stent from Market

By MedTech Intelligence Staff

…on results of the two-year COMPASS study. The COMPASS-XT study collected safety data on the subjects who participated in the COMPASS study for three more years, generating five years of…

…on results of the two-year COMPASS study. The COMPASS-XT study collected safety data on the subjects who participated in the COMPASS study for three more years, generating five years of…

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Tim Jennings, Custom Case Group
Soapbox

A New Frontier for AR/VR

By Tim Jennings

…(2017, March 16). How Virtual Reality Is Helping Heal Soldiers With PTSD. Retrieved from https://www.nbcnews.com/mach/innovation/how-virtual-reality-helping-heal-soldiers-ptsd-n733816 Fink, C. (2017, September 28). How VR Saves Lives In The OR. Retrieved from https://www.forbes.com/sites/charliefink/2017/09/28/how-vr-saves-lives-in-the-or/#502adf523099…

…(2017, March 16). How Virtual Reality Is Helping Heal Soldiers With PTSD. Retrieved from https://www.nbcnews.com/mach/innovation/how-virtual-reality-helping-heal-soldiers-ptsd-n733816 Fink, C. (2017, September 28). How VR Saves Lives In The OR. Retrieved from https://www.forbes.com/sites/charliefink/2017/09/28/how-vr-saves-lives-in-the-or/#502adf523099…

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

No Management Review?

By Dr. Christopher Joseph Devine

…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. ( July 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Anigan, Inc. Accessed August 27, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm615066.htm…

…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. ( July 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Anigan, Inc. Accessed August 27, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm615066.htm…

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Lutz Retzlaff
MEDdesign

How Start-Ups Are Trying to Conquer the Market

By Dr. Lutz Retzlaff

…that has enjoyed international expansion as well. Against this backdrop, this year’s MEDICA will be a hotspot for innovative young companies. As part of the “MEDICA Disrupt” initiative (held within…

…that has enjoyed international expansion as well. Against this backdrop, this year’s MEDICA will be a hotspot for innovative young companies. As part of the “MEDICA Disrupt” initiative (held within…

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Pediatric technologies

Developing a Cardiovascular Pediatric Device? You Could Win $100,000

By MedTech Intelligence Staff

Every year the Children’s National Health System holds its Pediatric Device Innovation Symposium, an event in which companies compete to win funding for the development of their pediatric products. This…

Every year the Children’s National Health System holds its Pediatric Device Innovation Symposium, an event in which companies compete to win funding for the development of their pediatric products. This…

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