FDA Clears Vertera’s New Interbody Fusion Device July 28, 2017 Unlike 3D-printed implants, the devices behave similarly to bone under compression. Read More
FDA Clears DarioHealth’s Glucose Meter and App July 25, 2017 The pocket-sized meter device syncs with a companion app, available on Android and iOS devices, which includes a nutrition guide and log. Read More
Masimo Scores CE Mark for RPVi Device July 24, 2017 The announcement comes the week after the company announced CE Mark approval for its Rainbow Super DCI-mini sensor. Read More
Biotronik Atrial Leadless ICD Line Scores FDA Approval July 21, 2017 The Intica device line is the first that does not require an atrial lead. Read More
FDA Clears First Neonatal MRI Device July 21, 2017 The device does not require a safety zone or radiofrequency shielded room. Read More
Voluntis Secures FDA Clearance and CE Mark for Digital Diabetes Management System July 21, 2017 Voluntis plans to launch the system in the European market in the near future. Read More
Edap Withdraws 510(k) Device Application to Redo Clinical Data July 21, 2017 The revised application will stay the same beyond the updated data. Read More
Cardiac Troponin Test Receives CE Mark July 19, 2017 The company will submit data for FDA clearance of the assay in 2018. Read More
FDA Approves EIT’s 3D-Printed Spinal Support Implants July 19, 2017 Titanium implants developed by the German company are already approved for more than 15 nations. Read More
TGA Maintains Metal-On-Metal Hip Replacement Recommendations July 19, 2017 The TGA issued the statement in light of revised guidance by the U.K.’s Medicines and Healthcare products Regulatory Agency. Read More
CSA Medical’s trueFreeze Catheter Tech Wins Expanded 510(k) Approval July 18, 2017 The system is indicated for cryosurgery in dermatological, gynecological and general surgery procedures. Read More
CFDA Approves Gilupi CTC Device July 18, 2017 The CellCollector was the first in vivo CTC isolation device to secure the CE approval. Read More