Sana Health Receives FDA "Breakthrough Device Designation" for Sana Device

LAFAYETTE, CO March 31, 2021

Sana Health, a Colorado-based medical device startup, has received Breakthrough Device designation status from the Food and Drug Administration for the Sana device, a wearable mask that uses audiovisual stimulation to guide the user into deep states of relaxation.

The Sana Device is a self-directed, low burden solution that is effective in relieving many of the symptoms of Fibromyalgia that can be easily adapted to the needs and schedule of the patient.  The benefits of using the singular Sana device may allow Fibromyalgia patients to lower or discontinue partially ineffective drug treatments that include unwanted side effects as well as to consolidate their treatment plan to focus on the most effective additional interventions.

The FDA Breakthrough Device Program is intended to help patients receive access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will work with Sana Health in multiple ways, including priority review, interactive communication regarding device development, and commercialization decisions.

Contacts: Richard Hanbury, CEO, Tasha Bond, COO