gavel

With End to Government Shutdown, Device Tax Delayed Two Years

By MedTech Intelligence Staff

…world,” said Joe Panetta, president and CEO of California life sciences industry association Biocom. “Nevertheless, Biocom continues to support permanent repeal of the tax and looks forward to working with…

…world,” said Joe Panetta, president and CEO of California life sciences industry association Biocom. “Nevertheless, Biocom continues to support permanent repeal of the tax and looks forward to working with…

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stethescope

Chronic Disease Management in Asia

By Ames Gross

…the chronic disease and intervene early to prevent further complications. The disease management industry in the United States is comprised of very large companies such as Eli Lilly, Merck-Medco Managed…

…the chronic disease and intervene early to prevent further complications. The disease management industry in the United States is comprised of very large companies such as Eli Lilly, Merck-Medco Managed…

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Zoll LifeVest

Zoll LifeVest Issue May Prevent Patients from Receiving Lifesaving Shock

By MedTech Intelligence Staff

…service” message and how to respond. The full details and instructions on how providers, patients and caregivers should respond to the LifeVest “call for service” are available on FDA’s website….

…service” message and how to respond. The full details and instructions on how providers, patients and caregivers should respond to the LifeVest “call for service” are available on FDA’s website….

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

Truth in Labeling

By Dr. Christopher Joseph Devine

…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (November 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. GPC Medical Ltd. Accessed January 15, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm589686.htm…

…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (November 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. GPC Medical Ltd. Accessed January 15, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm589686.htm…

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FDA

FDA and DoD Launch Program to Prioritize Device Development for Military

By MedTech Intelligence Staff

…program will ultimately allow us to implement a robust and enduring pathway across the entire agency to expedite access to such products as we fulfill our commitment to our Nation’s…

…program will ultimately allow us to implement a robust and enduring pathway across the entire agency to expedite access to such products as we fulfill our commitment to our Nation’s…

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Wearable sensors

Do Wearable Biosensors Improve Patient Outcomes?

By MedTech Intelligence Staff

…these sensors actually improve patient outcomes like weight or blood pressure? Investigators at Cedars-Sinai in Los Angeles sought out this answer by conducting a literature analysis of the clinical outcomes…

…these sensors actually improve patient outcomes like weight or blood pressure? Investigators at Cedars-Sinai in Los Angeles sought out this answer by conducting a literature analysis of the clinical outcomes…

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Alert

Becton Dickinson Receives FDA Warning Letter for Significant Violations

By MedTech Intelligence Staff

…to variability in test results in which specific Vacutainer blood collection tubes were used with Magellan Diagnostics’ LeadCare test systems. “Our inspection showed that BD violated the law by making…

…to variability in test results in which specific Vacutainer blood collection tubes were used with Magellan Diagnostics’ LeadCare test systems. “Our inspection showed that BD violated the law by making…

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Medical device recall

Edwards Recalls Delivery System Used for SAPIEN Heart Valve

By MedTech Intelligence Staff

Edwards LifeSciences has announced a recall of its Certitude Delivery System, which is used to deliver the company’s SAPIEN 3 transcatheter heart valve. The issue is a molding overflow defect…

Edwards LifeSciences has announced a recall of its Certitude Delivery System, which is used to deliver the company’s SAPIEN 3 transcatheter heart valve. The issue is a molding overflow defect…

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gavel

The Device Tax Returns

By MedTech Intelligence Staff

…hindrance to innovation, especially due to the fact that it hits the small companies the hardest. And these small companies may not benefit from the reform bill’s corporate tax cut…

…hindrance to innovation, especially due to the fact that it hits the small companies the hardest. And these small companies may not benefit from the reform bill’s corporate tax cut…

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

Happy New Year and MDRs

By Dr. Christopher Joseph Devine

…that you market: (1) May have caused or contributed to a death or serious injury. Compliance for Dummies Customer complaints and the review of customer complaints to ensure they do…

…that you market: (1) May have caused or contributed to a death or serious injury. Compliance for Dummies Customer complaints and the review of customer complaints to ensure they do…

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