Hello from Team Sana!
Last week the Sana team completed all the engineering and testing needed to comply with the FDA requirements and international standards on the device and confirmed that the product is ready for FDA to review. This is a huge milestone in terms of us confirming the safety and effectiveness of the product and we are excited to gather it all together to send to FDA in the coming weeks.
Last week, our final patients completed our study into use of the Sana device in management of fibromyalgia. We now have work to do to analyse that data, but are feeling really positive.
Please stay tuned as we have more important news coming in the next few weeks. We have a major study starting at Mount Sinai hospital and other developments that should help us get to rapid approval.
Our priority is to get FDA approval and to then allow as many eligible patients as possible to try Sana. To those of you who are on our waiting list, thank you for your patience. Getting a device approved by FDA is not a fast process, but it’s for the best of reasons and we are working as hard as we can to pass all necessary regulatory and clinical tests.
Once again, thank you all so much for your support and patience!
From the Team at Sana.