- Resonance Health (RHT) submits its LiverSmart device to the FDA for US regulatory clearance
- LiverSmart is the company’s newest AI medical device, reviewing chest CT scans of patients with suspected pulmonary embolism
- The device also combines two other regulatory cleared products, FerriSmart and HepaFat-AI
- The company says it hopes to avoid two separate MRI scanning sessions saving cost and enhancing convenience
- Resonance Health is up 4.76 per cent at 11 cents
Resonance Health (RHT) has submitted its LiverSmart device to the Food and Drug Administration (FDA) for US regulatory clearance.
LiverSmart is the company’s newest AI medical device, reviewing chest CT scans of patients with suspected pulmonary embolism.
The AI medical device also combines two other regulatory cleared products, FerriSmart and HepaFat-AI.
The combination places all three into a single multi-parametric MRI session, avoiding the need for multiple MRI appointments.
The company says it’s also working towards patients being able to obtain individual FerriSmart and HepaFat-AI reports in one session, avoiding cost and inconvenience.
The FDA application process for a medical device clearance can take between several weeks and months depending on whether the FDA has any questions or if additional information is required.
The company saiid LiverSmart may be eligible for two new US current procedural technology (CPT) codes recently published by the American Medical Association (AMA), becoming active on January 1 2022.
Resonance Health was up 4.76 per cent at 11 cents at 1:20 pm AEDT.