The ResApp Health Ltd (ASX: RAP) share price has returned from its trading halt and raced to a 52-week high this morning.
At the time of writing the digital health company's shares are up over 17% to a 52-week high of 29 cents.
Why is the ResApp share price racing higher again?
Investors have been buying the company's shares this morning after it announced that ResAppDx-EU has received Australian Therapeutics Goods Administration (TGA) approval as a Class IIa medical device and is now listed on the Australian Register of Therapeutic Goods.
ResAppDx-EU is the world's first smartphone-based diagnostic test for acute paediatric respiratory disease. It has been designed to be used by clinicians for the diagnosis of lower respiratory tract disease, croup, pneumonia, asthma/reactive airway disease and bronchiolitis in infants and children.
The software uses machine learning algorithms that analyse a patient's cough sounds to diagnose disease. Other than a smartphone, it does not require any additional hardware or accessories.
This news is a big positive for the company because most people will develop an acute respiratory tract infection every year and, according to management, these infections are the most common acute illnesses seen in primary care.
The release explains that upper respiratory tract infections account for 3-4 million visits to GPs in Australia every year, while lower respiratory tract infections cause an additional 3 million visits. Bronchiolitis and croup account for the majority of winter hospitalisations for children.
The CEO and managing director of ResApp, Tony Keating, said: "Achieving TGA approval is an important regulatory milestone that allows us to sell ResAppDx-EU in Australia, our home market. We believe that ResAppDx-EU will deliver strong health and economic benefits when used by clinicians in Australian emergency departments, urgent care clinics, GP offices and in the Australian telehealth industry, which has grown markedly in the last year."
This is the second announcement out of the company this week after Monday's positive top-line results from its prospective, blinded at-home obstructive sleep apnoea study.
Also climbing strongly on the All Ordinaries on Wednesday are the shares of Bellevue Gold Ltd (ASX: BGL) and ELMO Software Ltd (ASX: ELO) with gains of 3% and 4%, respectively.
