US Food and Drug Administration (FDA) has given a green card to Resonance Health’s ground-breaking machine learning solution ‘FerriSmart®’ that returns the quantification of liver iron concentration.
In the recent market release, Resonance Health Limited announced that US Food and Drug Administration (FDA) has granted the long awaited 510(k) clearance to the company’s FerriSmart® technology.
FerriSmart® is Resonance’s proprietary Artificial Intelligent (AI) solution that automatically analysis MRI scans and returns a liver iron quantification result within seconds. It is also cost effective compared to Resonance’s FerriScan® analysis. But the same high benchmark set by FerriScan® has been reportedly maintained in the FerriSmart® technology. Additionally, security against counterfeiting has been embedded through QR code for each report which allows patients and doctors to verify the authenticity of their reports in real-time.
With the receipt of this clearance, the company is now authorized to market its proprietary FerriSmart® for commercial distribution in the United States. Moreover, this clearance comes in line with two major regulatory clearance that the company has received in July 2018. It includes TGA – Therapeutic Goods Administration (Australia) and CE Mark (European Union) approving FerriSmart® as an artificial intelligence tool for use in liver iron quantification.
FDA’s clearance has approved on three major grounds, first, individuals’ liver iron concentration can be measured by FerriSmart® with systemic iron overload either confirmed or suspected. Second, Resonance’s FerriSmart® technology can monitor patients with sickle cell disease receiving blood transfusions or transfusion dependent thalassemia patients to analyze liver iron burden in them. Last, FerriSmart® provides assistance in monitoring and identifying thalassemia patients who are non-transfusion-dependent and receiving therapy with deferasirox.
Now, Resonance’s FerriSmart® is TGA, CE Mark and FDA cleared. With all these three approvals in place, the company commercializes FerriSmart® as an artificial intelligent tool in the radiology workflows. Clinicians and radiologists across the globe can access the FerriSmart® services on ‘pay per use’ service basis through company’s channel partner Blackford analysis or via Resonance Health’s own cloud-based portal.
Resonance Health Limited (ASX: RHT) is focused on developing high-end medical device software for healthcare sector. Its stock has taken a long leap of 42.857% to close at $0.060 on 6 December 2018. Looking at the bullish market trends, it would not be a surprise to see RHT setting a new high on Australian Securities Exchange, surpassing its current high of $0.064.
In today’s trading session, the stock last traded at price to earnings ratio of 70.00x with market capitalization of $16.9 million.
This website is a service of Kalkine Media Pty. Ltd. A.C.N. 629 651 672. The website has been prepared for informational purposes only and is not intended to be used as a complete source of information on any particular company. Kalkine Media does not in any way endorse or recommend individuals, products or services that may be discussed on this site. Our publications are NOT a solicitation or recommendation to buy, sell or hold. We are neither licensed nor qualified to provide investment advice.