The Resonance Health Limited (ASX: RHT) share price is shooting the lights out on Thursday. This comes after the company announced it has received a 510(k) clearance from the US Food and Drug Administration (FDA) regarding its newest medical device.
At the time of writing, the Australian healthcare technology and services company's shares are up 36.36% to 15 cents. In comparison, the All Ordinaries Index (ASX: XAO) is down 0.16% to 7,827.5 points.
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What did Resonance Health announce?
The Resonance Health share price is surging today after the company advised the United States FDA has cleared the pathway for it to begin commercialisation for LiverSmart.
LiverSmart is a software medical device that provides a more comprehensive assessment of a person's liver iron and liver fat. The technology combines two of the company's existing health products, FerriSmart and HepaFat-AI, into a single multi-parametric MRI session.
Instead of obtaining separate individual reports from either product, LiverSmart saves costs and improves convenience for the customer and clinician.
Furthermore, Resonance Health believes LiverSmart may be eligible for two new US (Cat III) Current Procedural Technology (CPT) codes. It is awaiting definitive determination of LiverSmart's eligibility for these codes from a US-certified CPT coder.
Obtaining the codes allows reimbursement by government payers such as Medicare and Medicaid, and private payers including private health insurers. This becomes more enticing to a paying consumer as a portion of the expenses is refunded.
It's expected the codes will be active some time in January 2022.
Commenting on the news driving the Resonance Health share price, chief scientific officer Dr Wenjie Pang said:
We are delighted that the FDA has moved so quickly in clearing LiverSmart, with this being the fastest FDA clearance we have achieved for any of our FDA cleared medical devices, which speaks to the quality and depth of experience we have in navigating the FDA regulatory framework.
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. We've used AI in this device to further evolve our products and to achieve rapid turnaround and enhanced scalability.
Resonance Health share price summary
Over the last 12 months, the Resonance Health share price has lost around 35%.
Based on today's price, Resonance Health presides a market capitalisation of roughly $62.22 million.
