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Mortality Outcomes of Vertebral Augmentation for Osteoporotic Vertebral Compression Fractures

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Fast facts

In a meta-analysis of more than 2 million patients, those with osteoporotic vertebral compression fractures who underwent vertebral augmentation were 22% less likely to die at up to 10 years after treatment than those who received nonsurgical treatment, RSNA 2020

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Radiology JournalRadiology Journal

Re-entry guidance for medical device representatives

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AdvaMed Joins AORN, AHA in Issuing “Re-entry Guidance for Health Care Facilities and Medical Device Representatives

Updated news

In response to the COVID-19 pandemic, hospitals and surgical facilities nationwide paused elective surgical procedures and other nonemergent and nonessential services, limiting physical access to facilities for nonessential health care personnel, patient visitors, and medical device representatives.

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COVID-19 tests : Are they all legit ?

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FDA is working with U.S. Government partners, including CDC, and international partners to address the coronavirus disease 2019 (COVID-19) outbreak.

Fast facts

It is very confusing right now and there is a lot of false information circulating. At this time, there is NO test kit available for home testing. As Initial Importer, we make sure to assist manufacturers and distributors to understand the rules and regulations for importing this kind of products.

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FDA websiteFDA website

Importing masks in the US : How to keep track !

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FDA is working with U.S. Government partners, including CDC, and international partners to address the coronavirus disease 2019 (COVID-19) outbreak.

Fast facts

Guidelines from health authorities are changing by the hour. It’s very difficult to keep track. What was true yesterday has been modified today and probably will be tomorrow. We have been in communication with the FDA, and even they are telling us to keep an eye on their website. On Saturday one FDA agent told us this :

This is a very fluid situation and the guidance can change at any time.”

It is the wild wild west! So let’s try to make it easier to understand.

As an Initial Importer our focus is on 2 major topics. First is to make sure we understand where the FDA stands on registration, listing and premarket numbers especially in the context of Emergency Use Authorization (EUA). The second is in regard to importation itself; what information needs to be submitted to the FDA and the US Customs and Border Protection (CBP).

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