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The Vascade MVP venous closure system designed to help heal multi-site vascular access points following minimally invasive EP procedures, that has been granted premarket approval by the FDA. The system places a collagen patch on the outside of each blood vessel puncture site, nothing is left inside the vessel, and the collagen is gradually resorbed …
Following FDA classification as a Class II device, the latest iteration of the Apple smartwatch containing an app unlocking the wrist-based ECG functionality will be available to USA consumers in late 2018. The FDA cleared electrocardiogram is now official classified as a medical device that is capable of altering users to abnormal heart rhythms; accelerometer …
Mylan’s EpiPen and EpiPen Jr epinephrine autoinjectors are the first generic versions to gain FDA approval, in a move that can help increase access to emergency treatment for allergic reactions; and is part of broader federal mandates to help lower costs of medications that not protected by patents or exclusions. Approval was granted for Teva …