Those who want to use Horos or OsiriX as a medical image viewer are sometimes concerned as to whether the software has been approved by the FDA. While we will get to the answer, the real question is whether or not Horos or OsiriX meet the standards required for your specific use case.
With that said, no one single answer can apply for every person reading this article. There are a vast number of regulatory organizations around the world, from Health Canada to the European Union, responsible for approving software for medical use, and the regulations vary from country to country and industry to industry.
Please note that this article does not constitute legal advice, and you should always consult with your attorney or another legal expert if you're uncertain about the legal implications of a decision about your practice.
With all that said, are Horos and OsiriX FDA-approved?
What Is FDA Approval?
Simply put, a product with "FDA approval" means that the FDA has certified that the medical benefits of the product outweigh the potential risks of its use. The FDA is responsible for approving a wide range of medical items, from drugs and food additives to medical devices. Once approval has been granted, the item is deemed clinically compliant and can be used in a clinical environment, as long as it continues to meet this standard.
In order to obtain FDA approval, the software vendor must fulfill several requirements. The software must have a manual, and the vendor must have policies and procedures in place in order to notify users of issues with the software that have an impact on clinical practice. In addition, there must be a support system where the software's customers can contact the vendor, ask questions and obtain technical support. As the software is updated, fixing bugs and providing new features and functionalities, it must be reviewed at regular intervals by the FDA in order to obtain approval again.
As such, similar to OsiriX Lite, Horos has not been formally FDA-cleared for diagnosis. While OsiriX MD is FDA/CE-certified, it carries with it a $699 price tag. However, there are many use cases that do not require FDA clearance.
What Does This Mean for Horos and OsiriX?
The important thing to consider is whether or not your specific use case requires an FDA-approved viewer. In cases other than diagnosis, Horos may be just fine. It is important to remember that just because software does not carry the FDA approval does not mean that the quality of the product is any less, just that it hasn't been submitted or passed through the FDA's scrutiny. If your use case includes teaching, learning, research, discussions, demonstration, veterinary, review of anonymized data or use in a non-FDA regulated region for instance, FDA clearance may not be necessary.
For example, a surgeon may choose to use Horos during a meeting with a patient to display their latest medical imaging and discuss their upcoming surgery. They would have previously relied on the interpretation of a radiologist who used an FDA-compliant software to make the diagnosis, for example, Purview ViVA's cloud-based viewer which is FDA-cleared, Health Canada-licensed and CE-marked for diagnostic medical imaging.
The added value of viewers such as Purview ViVA is that they are cloud-based, thus enabling anywhere access to images on any device, as opposed to having images available only locally on Mac products, such as is the case with OsiriX MD.
The Right Question
The true underlying question here shouldn't be "Are Horos and OsiriX FDA-approved?" but rather "Is it appropriate to use Horos or OsiriX for my specific use case?"
Again, when questions like these arise about the proper use of Horos or OsiriX, it is important to keep in mind that you should consult with your legal counsel and also consider the limitations of such software when considering your practice's needs.
