ResApp Health (ASX: RAP) has finally locked-in Australian Therapeutic Goods Administration for using its smartphone-based diagnostic technology to determine respiratory disease in adults.
This latest milestone follows TGA approval in October to use its respiratory diagnostic technology in paediatrics.
ResApp’s smartphone application ResAppDx-EU version two can now be used to diagnose respiratory disease in both adults and children and is approved as a Class IIa medical device which is now listed on the Australian Register of Therapeutic Goods.
“We are pleased that our lead produce ReAppDx-EU is now approved for use on both adults and children in Australia and Europe,” ResApp chief executive officer and managing director Tony Keating said.
With most people developing an acute respiratory tract infection each year, it is the most common acute illness seen in clinical health settings.
Current diagnosis of respiratory disease is complex and subjective – involving a combination of clinical judgement with diagnostic aids such as stethoscope, imaging, blood and sputum tests.
ReAppDX-EU is a software app that clinicians can use to diagnose lower respiratory tract diseases such as croup, pneumonia, asthma exacerbation and chronic obstructive pulmonary disease.
The software uses machine learning algorithms to analyse a patient’s cough sounds to diagnose the disease.
It only requires a smartphone and no other accessories to operate the software.
“ResAppDx-EU offers strong health and economic benefits to telehealth providers, emergency departments and urgent care clinics in Australia and Europe, and we are excited by the scale of the opportunity and our unique position in the market,” Mr Keating said.
“We are now growing our commercial team to support our sales, marketing and business development activities in these regions, and we are pleased to have a growing number of opportunities at various stages in our commercial pipeline.”
In November last year, ResApp revealed its test would be integrated into Australia’s telehealth software platform Coviu.
The current integration process is underway and was due to take four months all up.