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
FDA Clears Masimo’s Updated Cerebral Oxygenation Monitor September 10, 2019 The new indices give clinicians more visibility into changes in cerebral oxygen saturation. Read More
Bardy’s 14-Day Ambulatory Cardiac Patch Monitor Cleared September 10, 2019 The extended duration may help detect less frequent arrhythmias. Read More
Netech Grabs FDA Clearance for Defibrillator/ Pacemaker Analyzer September 10, 2019 The device measures peak discharge voltage and current. Read More
Occlutech Grabs CE Mark for Atrial Flow Regulator September 9, 2019 The device comes in a variety of sizes to allow individualized treatment. Read More
FDA Hands SoniVie Breakthrough Designation for PAH Treatment September 9, 2019 The ultrasound catheter is placed in the pulmonary artery during a heart catheterization procedure. Read More
Mevion’s CBCT Imaging System Cleared by FDA September 6, 2019 The imaging system works with pencil beam scanning technology for precise radiation treatments. Read More
LAP’s Positioning Laser Gains 510(k) Clearance September 6, 2019 The device uses a remote control for quick adjustments of the laser’s position and focus. Read More
Shockwave Gains Breakthrough Designation for Catheter September 5, 2019 The tool uses sonic pressure waves to break up calcium buildup and enable stent deployment. Read More
Gala Therapeutics Earns CE Mark for Chronic Bronchitis Treatment September 4, 2019 The company plans a postmarket study at European respiratory centers. Read More