- Resonance Health (RHT) has received Australian Therapeutic Goods Administration (TGA) approval for its liver fat software, HepaFat-AI
- HepaFat automatically analyses magnetic resonance imaging datasets to assess liver fat in patients
- The TGA approval means the device is in line with regulatory requirements and allows the company to sell the product in Australia
- Notably, Resonance received U.S. Food and Drug Administration approval for HepaFat in December
- On the market this afternoon, Resonance is up 12.8 per cent and is trading at 22 cents per share
Resonance Health (RHT) has received Australian Therapeutic Goods Administration (TGA) approval for its liver fat software, HepaFat-AI.
HepaFat automatically analyses magnetic resonance imaging (MRI) datasets to assess liver fat in patients.
TGA approval means the device is in line with regulatory requirements and allows the company to sell the product in Australia.
Notably, Resonance received U.S. Food and Drug Administration approval for HepaFat in December.
The company plans on marketing HepaFat to radiologists and physicians involved in the routine clinical diagnosis and management of patients with confirmed or suspected fatty liver disease.
HepaFat also intends to be marketed towards pharmaceutical companies involved in the nonalcoholic steatohepatitis (NASH) drug development due to the high standard and reproducible nature of the artificial intelligence device.
“As HepaFat-AI is validated for all the major MRI scanner makes and models, it is ideally suited for these purposes, particularly in NASH multi-center trials which
require standardised workflows to ensure clinically meaningful data is generated,” Resonance said.
“Moreover, as HepaFat-AI can deliver data in near real-time, investigators can respond rapidly particular if adaptive trial protocols implemented, a particular advantage when compared to current NASH studies,” the company added.
On the market this afternoon, Resonance is up 12.8 per cent and is trading at 22 cents per share at 12:19 pm AEDT.