Aatru Medical Gets 510(k) Clearance for Surgery Management System

The FDA has granted Aatru Medical 510(k) clearance for its negative pressure surgical incision management system, abbreviated as NPSIMS.

Cleveland, Ohio-based Aatru says the NPSIMS does not need the expensive electro-mechanical pump, battery, and electronics found in most other negative pressure wound therapy systems for closed surgical incision applications.

The single-use device, which includes a preassembled dressing, significantly reduces the rate of wound infection compared with standard postoperative dressings, the company says.