- Resonance Health (RHT) receives United States Food & Drug Administration (FDA) for its new medical device LiverSmart
- With this FDA approval, LiverSmart will be able to be marketed and sold in the US, which is the company’s largest customer base
- LiverSmart is a medical imaging analysis product and combines two existing products, FerriSmart and HepaFat-AI
- It is the fastest FDA clearance the company has achieved
- On the market, Resonance is up 36.4 per cent and trading at 15 cents
Healthcare tech stock Resonance Health (RHT) has received United States Food & Drug Administration (FDA) for its new medical device LiverSmart.
With this FDA approval, LiverSmart will be able to be marketed and sold in the US, which is the company’s largest customer base.
LiverSmart is a medical imaging analysis product and combines two existing products, FerriSmart and HepaFat-AI, into a single multi-parametric magnetic resonance imaging (MRI) session.
This avoides the need for multiple MRI appointments and delivers a more comprehensive assessment of a person’s liver.
The company believes LiverSmart may be eligible for two new US (Cat III) Current Procedural Technology (“CPT”) codes.
CPT codes are a national procedural coding set maintained by the American Medical Association, and recognised by US government agencies.
The codes are used by physicians and health care professionals for reporting and tracking medical services.
It is the fastest FDA clearance the company has achieved.
Chief Scientific Officer Wenjie Pang is delighted that the FDA moves so quickly in clearing LiverSmart.
“LiverSmart is a natural evolution of our existing product offering and responds to the growing trend in software as medical devices (SaMD), for more holistic assessment of organs,” said Dr Pang.
“We’ve used AI in this device to further evolve our products and to achieve rapid turnaround and enhanced scalability.”
On the market, Resonance was up 36.4 per cent, trading at 15 cents at 11:15 am AEDT.