Pleurodesis

Pleural Dynamics Receives FDA 510(k) Clearance for its Novel ACES™ Automatic Continuous Effusion Shunt System

Retrieved on: 
星期四, 十月 19, 2023
FDA, Health, Medical Devices, Pleurodesis, Critical Care Medicine (journal), Pleural cavity, Pleural effusion, Interventional radiology, Drainage, Abdomen, Patient, Food and Drug Administration, Food, Hospital, Medical device

Pleural Dynamics, a medical device company that is building solutions for chronic, recurrent fluid collections in the body, today announced that the Company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ACES™ Automatic Continuous Effusion Shunt System.

Key Points: 
  • Pleural Dynamics, a medical device company that is building solutions for chronic, recurrent fluid collections in the body, today announced that the Company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ACES™ Automatic Continuous Effusion Shunt System.
  • Pleural Dynamics’ patented ACES™ System addresses these shortcomings1 with its’ one-piece, fully implanted system that can be placed during a short hospital stay.
  • With this FDA 510(k) clearance, Pleural Dynamics will begin real-world clinical use of the ACES™ System with select hospitals and health systems.
  • Pleural Dynamics’ latest technology will play a vital role in improving the lives of patients with intractable pleural effusion.