ResApp Health Limited (ASX:RAP)
has announced a positive outcome from its recent pre-submission meeting with the US FDA regarding the company’s diagnostic mobile software application, ResAppDx.
During the meeting ResApp received targeted feedback from the FDA regarding the proposed US regulatory pathway, clinical study protocols and data requirements.
The company specializes in developing smartphone medical applications for the diagnosis and management of respiratory disease.
ResApp says it will now pursue a direct de novo pre market submission for ResAppDx, initially for pediatric use.
ResApp reported a net loss of $1.5 million at 31 December 2015.