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- Mobile healthcare company ResApp Health (RAP) has filed a pre-submission package with the U.S. Food and Drug Administration (FDA)
- The company has also requested a meeting to progress the potential clearance of a prescription-only software used to detect respiratory illnesses
- A pre-submission package allows the FDA to provide feedback on a product to help the company get its device to market as soon as possible
- A meeting will now be scheduled to discuss potential approval pathways and further requirements
- ResApp’s mobile software device uses machine learning algorithms to analyse the sound of patient’s cough to diagnose diseases and provide accurate information
- ResApp is up 2.99 per cent on the market this morning with shares trading at 6.9 cents
Mobile healthcare company ResApp Health (RAP) has filed a pre-submission package with the U.S. Food and Drug Administration (FDA).
The company has also requested a meeting with the FDA to progress the potential clearance of a prescription-only software used to detect respiratory illnesses.
A pre-submission package allows the FDA to provide feedback on a product before a 510(k) is submitted, which determines whether a product is safe and efficient to use.
A meeting will now be scheduled to discuss potential approval pathways and further requirements.
“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 U.S.,” CEO and Managing Director Dr Tony Keating said.
“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,” he added.
ResApp’s mobile software device, ResAppDx-EU allows clinicians to diagnose multiple respiratory problems.
It uses machine learning algorithms to analyse the sound of a patient’s cough to diagnose diseases and provide quick and accurate information.
It is a software-only solution that runs on smartphones, meaning it does not require any additional hardware or accessories.
ResApp is up 2.99 per cent on the market this morning with shares trading at 6.9 cents at 10:32 am AEDT.
