Advanced Cooling Therapy (ACT) has received 510(k) clearance from the US Food and Drug Administration (FDA) for use of its Esophageal Cooling Device (ECD) with the Altrix Precision Temperature Management System by Stryker®.
http://finance.yahoo.com/news/breakthrough-start-advanced-cooling-therapy-150000100.html
Breakthrough Start-up Advanced Cooling Therapy Receives 510(k) Clearance from FDA for Use with New Control Unit