Consumer Information on: Gastric Emptying Breath Test (GEBT)

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: Gastric Emptying Breath Test (GEBT)…

FDA Voice: FDA and CMS Form Task Force on LDT Quality Requirements

By: Jeffrey Shuren, M.D., J.D. and Patrick H. Conway, MD, MSc Health care providers and their patients expect that laboratory tests used in clinical management of patients should be consistent and of high quality. Jeff Shuren, M.D., J.D. Under FDA’s proposed framework for the oversight of laboratory developed tests (LDTs), outlined in draft guidance documents issued…

Problem with Quality of Mammograms at J. Bruce Jacobs M.D., Inc., doing business as Huntington Radiology in Huntington Park, California: FDA Safety Notification

Date Issued: April 13, 2015 Audience: Patients who had a mammogram at J. Bruce Jacobs M.D., Inc., doing business as Huntington Radiology, located in Huntington Park, California any time on or after September 8, 2014. Health care providers who have referred patients to J. Bruce Jacobs M.D., Inc., doing business as Huntington Radiology for a…

Consumer Information on: Impella 2.5 System

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: Impella 2.5 SystemApplicant: ABIOMED, Inc.Address:…