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Summary Information for: Blazer Open-Irrigated Ablation Catheter System
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Meeting Notice: April 20, 2016 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting…
Summary Information for: Sharps Terminator
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Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails
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Added Webcast Archive to Public Workshop
This workshop aimed to examine potential biomarkers, discuss the challenges and solutions related to biomarker development methodologies, and establish strategies for data standardization, sharing and analysis of big data sets for Traumatic Brain Injury (TBI). By convening the relevant stakeholders, the goal was to obtain input on the scientific, clinical, patient and regulatory considerations associated with…
The FDA recognizes the value of medical device innovation to address unmet clinical needs and…
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A variety of diseases can affect the appearance of nails, including fungal infection.
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Archived Webcast and Presentation Slides added to Public Workshop
The Food and Drug Administration (FDA) announced the following public workshop titled “Patient and Medical Professional Perspectives on the Return of Genetic Test Results.” The purpose of this workshop was to understand patient and provider perspectives on receiving genetic test results. The topic(s) discussed focused on better defining the specific information patients and providers prefer…
Emergency Use Authorizations: OraQuick® Ebola Rapid Antigen Test (OraSure Technologies, Inc.) – For Use with Cadaveric Oral Fluid
OraQuick® Ebola Rapid Antigen Test (OraSure Technologies, Inc.) – For Use with whole Blood – July 31, 2015 On July 31, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the OraQuick® Ebola Rapid Antigen Test for the presumptive detection of Ebola Zaire virus (detected in the West Africa…