Alert

Five More Deaths, FDA Alerts on Liquid-Filled Intragastric Balloons

By MedTech Intelligence Staff

…FDA approved labeling changes that indicated deaths could be associated with the above-mentioned devices. The agency is also monitoring complications associated with device placement and use, which includes perforation of…

…FDA approved labeling changes that indicated deaths could be associated with the above-mentioned devices. The agency is also monitoring complications associated with device placement and use, which includes perforation of…

Continue reading

Active Implants, Compamed

Trending: Innovation in Active Implant Technology

By Klaus Jopp

…new combinations of types of technology and the integration of electronics, smaller components, high frequency and wireless technology as well as monitoring, recording and control systems are market drivers for

…new combinations of types of technology and the integration of electronics, smaller components, high frequency and wireless technology as well as monitoring, recording and control systems are market drivers for

Continue reading

Medtech, innovation

FDA Launches Innovation Challenge to Fight Opioid Misuse and Abuse

By MedTech Intelligence Staff

…to devices that meet statutory criteria. “This innovation challenge is an example of the FDA’s commitment to an all-of-the-above approach to confront the opioid epidemic, including helping those currently addicted…

…to devices that meet statutory criteria. “This innovation challenge is an example of the FDA’s commitment to an all-of-the-above approach to confront the opioid epidemic, including helping those currently addicted…

Continue reading

MedTech Intelligence

Five Most Popular Articles of 2018 (So Far)

By MedTech Intelligence Staff

…https://medtechintelligence.com/feature_article/new-mdr-opportunity-knocks/ 3. IQ, OQ and PQ: The Backbone of Your Quality System https://medtechintelligence.com/feature_article/iq-oq-pq-backbone-quality-system/ 2. Becton Dickinson Receives FDA Warning Letter for Significant Violations https://medtechintelligence.com/news_article/becton-dickinson-receives-fda-warning-letter-significant-violations/ 1. New EU MDR Regulations and…

…https://medtechintelligence.com/feature_article/new-mdr-opportunity-knocks/ 3. IQ, OQ and PQ: The Backbone of Your Quality System https://medtechintelligence.com/feature_article/iq-oq-pq-backbone-quality-system/ 2. Becton Dickinson Receives FDA Warning Letter for Significant Violations https://medtechintelligence.com/news_article/becton-dickinson-receives-fda-warning-letter-significant-violations/ 1. New EU MDR Regulations and…

Continue reading

Kevin Becker, Spectralytics
MEDdesign

Working with Your Component Manufacturer to Mitigate Risk

By Kevin Becker

…leaves the component manufacturer in the dark. Component manufacturers understand the sensitivity around this topic, as OEMs see this information as proprietary. Yet, sharing more information with the component manufacturer…

…leaves the component manufacturer in the dark. Component manufacturers understand the sensitivity around this topic, as OEMs see this information as proprietary. Yet, sharing more information with the component manufacturer…

Continue reading

MedTech intelligence

Privacy Policy

…gdprrequests@foodsafetytech.com gdprrequests@medtechintelligence.com gdprrequests@foodsafetytech.com. Disclaimer of liability: This website is compiled and maintained with the utmost care. Nevertheless, we cannot guarantee the accuracy, completeness and freedom of errors of the data…

…gdprrequests@foodsafetytech.com gdprrequests@medtechintelligence.com gdprrequests@foodsafetytech.com. Disclaimer of liability: This website is compiled and maintained with the utmost care. Nevertheless, we cannot guarantee the accuracy, completeness and freedom of errors of the data…

Continue reading

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

Company Ignores FDAā€™s Request to Cease Commercial Distribution

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. (April 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. (April 2018). Inspections, Compliance, Enforcement, and…

Continue reading

Liver

Liver Disease: A Growing Problem in Asia

By Ames Gross

…early stages. The device, FibroTouch, is the world’s first image-guided non-invasive liver fibrosis diagnostic system. It can complete a liver examination in two minutes and give immediate quantitative results of…

…early stages. The device, FibroTouch, is the world’s first image-guided non-invasive liver fibrosis diagnostic system. It can complete a liver examination in two minutes and give immediate quantitative results of…

Continue reading

Medtronic

Medtronic Recalls MindFrame Capture LP Revascularization Device

By MedTech Intelligence Staff

…bloodstream—and this issue and/or the attempt to remove the device could lead to complications that include bleeding, further blockage of blood vessels, more severe stroke symptoms or death. In the…

…bloodstream—and this issue and/or the attempt to remove the device could lead to complications that include bleeding, further blockage of blood vessels, more severe stroke symptoms or death. In the…

Continue reading