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Tag: US FDA


Biomarker, Innovation

Daxor seeks US FDA approval for blood volume analyser 

January 3, 2024

Via: Medical Device Network

Daxor Corporation is seeking approval from the US Food and Drug Administration (FDA) for its next-generation blood volume analyser, Daxor BVA. Daxor BVA is designed for rapid, simple, and bedside patient care. The company submitted to the FDA through the […]


Innovation, Medical Devices

US FDA approves Edwards’ valve repair system to treat DMR patients

September 16, 2022

Via: Medical Device Network

The US Food and Drug Administration (FDA) has approved the PASCAL precision transcatheter valve repair system from Edwards Lifesciences for the treatment of degenerative mitral regurgitation (DMR) patients. The company has designed the system for transcatheter edge-to-edge repair (TEER) of […]


Biomarker, Innovation

US FDA grants 510(k) clearance for DiaSorin’s Covid-19 Direct kit

September 14, 2022

Via: Medical Device Network

The US Food and Drug Administration (FDA) has granted 510(k) clearance for DiaSorin’s Simplexa COVID-19 Direct kit. The Simplexa COVID-19 Direct kit has been designed for detecting the SARS-CoV-2 virus directly from nasopharyngeal or nasal swab samples. It is developed […]


Biomarker, Innovation

Quest Diagnostics receives EUA from US FDA for monkeypox PCR test

September 8, 2022

Via: Medical Device Network

Quest Diagnostics has received US Food and Drug Administration (FDA) emergency use authorization (EUA) for its monkeypox polymerase chain reaction (PCR) test. The latest move follows a declaration of monkeypox as a public health emergency by the US Department of […]


Innovation, Medical Devices, Regulatory

US FDA approves Boston Scientific’s brain stimulation device

December 12, 2017

Via: medicaldevice-network.com

The US Food and Drug Administration (FDA) has approved Boston Scientific’s Vercise Deep Brain Stimulation (DBS) System for the treatment of Parkinson’s disease symptoms. A DBS system is designed to trigger a targeted region of the brain through implanted leads […]