- ASX-listed medical imaging company Resonance Health has obtained CE marking to sell its device within the EEA.
- Resonance Health will provide HepaFat-AI to radiologists, physicians, and pharmaceutical companies.
- With the CE marking, Resonance Health has a total of three marketing approvals for HepaFat-AI.
A global leader in developing non-invasive diagnostic medical imaging solutions, Resonance Health Limited (ASX:RHT) updated the market that it had obtained a CE mark for HepaFat-AI. The device is based on fully-automated artificial intelligence software for the assessment of liver fat.
Let us dive deep and discuss RHT’s regulatory achievement in detail-
RHT can distribute and supply its Device in Australia, Europe, and the US
With the CE mark, Resonance has secured a total of three clearance for its device HepaFat-AI, including FDA and TGA approval, to distribute HepaFat-AI. With these approvals, the Company can lawfully distribute and supply its device across Australia, the European Economic Area (EEA) and the US.
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The Company obtained clearance for the device from the US Food & Drug Administration (FDA) in December 2020, and from Australia’s Therapeutic Goods Administration (TGA) in February 2021.
CE marking of the device indicates that it is compliant with the requirements of Medical Device Directive 93/42/EEC for CE Marking and is registered for sale within the EEA.
HepaFat-AI automatically analyses datasets of MRI (magnetic resonance imaging) for assessment of liver fat in patients. With this, the device offers a comprehensive, multi-metric solution to doctors to evaluate individuals having confirmed or suspected fatty liver disease.
The device assesses fatty liver images and offers the below-mentioned information on the resultant patient report-
The physicians can use this information from the analysis to-
- Examine patients undertaking weight loss management.
- Screen the livers of donors for suitability in the transplant.
- Monitor patients having or suspected to have NAFLD, pancreatic insufficiency, NASH (non-alcoholic steatohepatitis), and drug-induced fatty liver.
- Resonance Health will market HepaFat-AI to physicians and radiologists involved in the routine clinical diagnosis as well as patients’ management with confirmed or suspected fatty liver indication.
- Clinicians and radiologists will have the access to HepaFat-AI via RHT’s cloud-based portal soon.
- The Company is also evaluating the use of radiology-based channel partners for assessment of the direct route to market.
- Resonance Health stated that the device would also be marketed to pharmaceutical companies engaged in NASH drug development because of the highly standardised as well as reproducible nature of the AI solution.
Further, the Company notified that it has started investigating reimbursement for HepaFat-AI in the US.
The Company is continuing additional work in machine learning (ML) with its focus on developing as well as implementing cutting-edge assistance tools for clinicians and radiologists to examine numerous disease states. Resonance stated that it would provide further updates as the work progresses.
Stock Information: On 24 February 2021, RHT shares were trading at A$0.215, in-line with the previous close (at AEDT 2:08 PM).