FDA Clears Siemens Healthineers’ Angiography Platform September 18, 2019 The imaging platform is for use in surgical, vascular, oncology and interventional cardiology procedures. Read More
DreaMed’s Insulin Dosing Software Earns Clearances September 17, 2019 The software is the first decision support system cleared for patients who use insulin pumps or blood glucose monitors, the company said. Read More
Healthy.io Gets FDA Clearance for Kidney Disease Diagnostic September 16, 2019 The test has the same capabilities as lab-based testing, the company said. Read More
Saluda Handed CE Mark for Spinal Cord Stimulator September 16, 2019 The system adjusts on every pulse to optimize stimulation. Read More
Rex Medical’s Peripheral Atherectomy Device Cleared September 16, 2019 The system uses a 72-watt power supply similar to a laptop charger, requires no capital equipment and takes only minimal time to set up. Read More
Qfix Receives FDA Clearance for Diagnostic Imaging Coil September 13, 2019 Images obtained with the immobilization system can be used for radiosurgery treatment planning. Read More
FDA Clears Coronary Artery Disease Intervention Planner September 13, 2019 The device allows physicians to consult prior to the procedure and visualize the treatment path. Read More
LumaCyte Grabs CE Mark for Cellular Analysis Platform September 13, 2019 The platform has potential for use in vaccine development, among other areas. Read More
FDA Grants Breakthrough Status on Checkpoint’s Electrostimulation Therapy System September 12, 2019 The device uses low-level electrical currents to stimulate a patient’s peripheral nerves and encourage nerve regeneration. Read More
HemoSonics’ New Diagnostic for Hemostasis System Gains CE Mark September 12, 2019 Test results are shown on a user-friendly interface that requires little training to interpret. Read More
Exact Imaging’s Transperineal Needle Guide Grabs CE Mark September 11, 2019 The needle biopsies sample prostate tissue to look for cancer cells. Read More
EBR Systems Nabs Breakthrough Status for Wireless Cardiac Pacing System September 11, 2019 The system provides better options for pacing locations. Read More