B. Braun receives FDA clearance for SpaceStation MRI
August 31, 2020 – B. Braun Medical Inc. (Bethlehem, PA) received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the SpaceStation MRI…
FDA
Roche receives FDA approval of FoundationOne Liquid CDx, comprehensive pan-tumor liquid biopsy test
August 28, 2020 – Roche (Basel, Switzerland) received U.S. Food and Drug Administration (FDA) approval for FoundationOne Liquid CDx, Foundation Medicine’s comprehensive pan-tumor liquid biopsy…
Abbott releases fast, $5 COVID-19 antigen test, free mobile app to display test results
August 27, 2020 – Abbott (Abbott Park, IL) has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its BinaxNOW…
Medtronic Evolut TAVR system receives updated U.S. labeling revising precaution for treatment of low-risk patients with bicuspid aortic stenosis
August 21, 2020 – Medtronic plc (Dublin, Ireland) announced that the U.S. Food and Drug Administration (FDA) has approved revised commercial labeling for the Evolut…
Masimo PVi receives FDA clearance as indicator of fluid responsiveness on mechanically ventilated patients
August 17, 2020 – Masimo (Irvine, CA) announced that PVi (pleth variability index) has received FDA clearance as a continuous, noninvasive, dynamic indicator of fluid…
FDA approves Roche’s Evrysdi (risdiplam) for treatment of spinal muscular atrophy (SMA) in adults, children
August 10, 2020 – Roche (Basel, Switzerland) received approval from the U.S. Food and Drug Administration (FDA) for Evrysdi (risdiplam) for the treatment of spinal…
Roche receives FDA authorization for Epstein-Barr virus quantitative test on the cobas 6800/8800 Systems
August 06, 2020 – Roche (Basel, Switzerland) announced that the U.S. Food and Drug Administration (FDA) has authorized the cobas EBV test. This is the…
Abbott announces start of study to evaluate new device to treat recurrent AFib
August 04, 2020 – Abbott (Abbott Park, IL) announced first enrollments in the TactiFlex PAF IDE study to evaluate a new device to treat people…
Medtronic receives FDA approval for two new products: InterStim Micro Neurostimulator, InterStim SureScan MRI leads
August 03, 2020 – Medtronic plc (Dublin, Ireland) received approval from the U.S. Food and Drug Administration (FDA) for its InterStim Micro neurostimulator and InterStim…
Quidel’s Sofia SARS Antigen FIA updates EUA performance data to 96.7% PPA vs PCR
Quidel’s Sofia SARS Antigen FIA updates EUA performance data to 96.7% PPA vs PCR