Pexels.com
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.
---
Medical Devices Approved by the FDA in 2019
| Date | Device Name | Category |
| June 6 | Eversense Continuous Glucose Monitoring System - P160048/S006 | Glucose Monitor |
| June 4 | Hintermann Series H3™ Total Ankle Replacement System - P160036 | Joint Replacement |
| May 31 | TransMedics OCS Lung System - P160013/S002 | Lung Donor |
| May 24 | The therascreen PIK3CA RGQ PCR Kit - P190001
and P190004 | Cancer |
| May 23 | NovoTTF™-100L System - H180002 | Cancer |
| May 16 | Neuroform Atlas® Stent System - P180031 | Stent |
| May 2 | VICI VENOUS STENT® System - P180013 | Stent |
| May 16 | Tack Endovascular System® (6F) - P180034 | Vascular |
| April 26 | XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate - P180014 | Perfusion System |
| April 23 | LOTUS Edge™ Valve System - P180029 | Heart Valve |
| April 16 | TransPyloric Shuttle/TransPyloric Shuttle Delivery Device - P180024 | Weight Loss |
| April 12 | therascreen® FGFR RGQ PCR Kit – P180043 | Laboratory Test |
| April 2 | TherOx DownStream System - P170027 | Oxygen Therapy |
| March 28 | Cerene Cryotherapy Device - P180032 | Menstrual Bleeding |
| March 16 | TRILURON™ - P180040 | Osteoarthritis |
| March 21 | OPTIMIZER Smart System - P180036 | Cardiovascular |
| March 14 | MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System - P100009/S028 | Vascular |
| March 13 | VENOVO Venous Stent System - P180037 | Stent |
| March 11 | Barricaid® Anular Closure Device (ACD) - P160050 | Cancer |
| March 1 | COVERA™ Vascular Covered Stent - P170042/S002 | Stent |
| Feb. 8 | VENTANA PD-L1 (SP142) Assay - P160002/S009 | Hernia |
| Feb. 6 | M6-C™ Artificial Cervical Disc - P170036 | Spine |
| Feb. 1 | MANTA Vascular Closure Device - P180025 | Vascular |
| Jan. 30 | Sangia Total PSA Test - P170037 | Prostate Cancer |
