The ResApp Health Ltd (ASX: RAP) share price is climbing higher today. This comes after the company provided an update of its prescription-only software application with the United States Food and Drug Administration (FDA).
At the time of writing, shares in the digital health company are trading 1.4% higher at 6.8 cents.
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What did ResApp announce?
In today's release, ResApp advised it has sent a pre-submission package to the FDA for clearance on its smartphone-based medical software application. The company also requested a meeting with the FDA to discuss how to obtain regulatory approval and any other requirements.
ResApp's latest software application uses machine-learning algorithms to detect cough sounds recorded by a smartphone's inbuilt microphone. This, in turn, will help healthcare professionals identify if a patient is suffering from lower respiratory tract illness.
The company confirmed the benefits of the medical application's technology in its SMARTCOUGH-C-2 and Breathe Easy clinical trials.
If approved, ResApp said the prescription-only software would help users make informed decisions about their healthcare.
Words from the CEO
ResApp CEO and managing director Dr Tony Keating commented:
Submitting this pre-submission package and meeting request is an important first step in our re-engagement with the FDA that will provide a valuable opportunity for the company to discuss the potential pathways for the clearance of our cough-based analysis technology for use in the US.
We expect to have a number of meetings with the agency this year to ensure that the company is well positioned and to provide any additional details that might be required. ResApp looks forward to working cooperatively with the FDA over the coming months to delineate a path forward for its offering.
About the ResApp share price
The ResApp share price has tumbled more than 70% in the past 12 months, making it one of the poorer performers on the All Ordinaries Index (ASX: XAO).
ResApp has a market capitalisation of $51.5 million based on the current share price.
