Saturday, August 24, 2019

Saturday, August 24, 2019

24 medical devices OK’d by FDA so far this year


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Twenty-four medical devices have been approved as of June 18 for prescribed uses, according to the federal Food and Drug Administration.

The FDA’s 2019 Device Approvals page offers information on appropriate medical uses for the devices. 

Patients can use this information, along with advice from doctors and other sources, to make a decision on whether one of the devices would help with their conditions, the FDA said.

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Medical Devices Approved by the FDA in 2019

DateDevice NameCategory
June 6Eversense Continuous Glucose Monitoring System - P160048/S006Glucose Monitor
June 4Hintermann Series H3™ Total Ankle Replacement System - P160036Joint Replacement
May 31TransMedics OCS Lung System - P160013/S002Lung Donor
May 24The therascreen PIK3CA RGQ PCR Kit - P190001

and P190004

Cancer
May 23NovoTTF™-100L System - H180002Cancer
May 16Neuroform Atlas® Stent System - P180031Stent
May 2VICI VENOUS STENT® System - P180013Stent
May 16Tack Endovascular System® (6F) - P180034Vascular
April 26XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate - P180014Perfusion System
April 23LOTUS Edge™ Valve System - P180029Heart Valve
April 16TransPyloric Shuttle/TransPyloric Shuttle Delivery Device - P180024Weight Loss
April 12therascreen® FGFR RGQ PCR Kit – P180043Laboratory Test
April 2TherOx DownStream System - P170027Oxygen Therapy
March 28Cerene Cryotherapy Device - P180032Menstrual Bleeding
March 16TRILURON™ - P180040Osteoarthritis
March 21OPTIMIZER Smart System - P180036Cardiovascular
March 14MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System - P100009/S028Vascular
March 13VENOVO Venous Stent System - P180037Stent
March 11Barricaid® Anular Closure Device (ACD) - P160050Cancer
March 1COVERA™ Vascular Covered Stent - P170042/S002Stent
Feb. 8VENTANA PD-L1 (SP142) Assay - P160002/S009Hernia
Feb. 6M6-C™ Artificial Cervical Disc - P170036Spine
Feb. 1MANTA Vascular Closure Device - P180025Vascular
Jan. 30Sangia Total PSA Test - P170037Prostate Cancer
Source: U.S. Food and Drug Administration

Organizations in this Story

U.S. Food and Drug Administration (FDA)

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FDA Reporter