Moving Forward

 

 

Our immediate future will be focused on optimizing and improving our prototype. A few specific things we're exploring are improving the resolution of our coverage of the lungs by adding more transducers, identifying more features to strengthen our classifier, and collecting and training our software on a larger pool of normal lung sounds.

 

We plan to apply for an FDA Class II Investigative Device Exemption in order to shorten the regulatory pathway to get our device approved. While the approval process is underway, we will get IRB approval to begin studying our device in the hospital setting. Clinical studies will allow us to evaluate how our device performs on actual sick patients, as well as how it's received by doctors and other healthcare workers. Based on these results, we will do further iterations of product development and testing until our customers needs are met. 

 

After successful clinical trials and FDA approval, expect to see us on the market by 2017.