iQ-FUSION receives Mammo Clearance by FDA

iQ-FUSION is our zero-footprint viewer for advanced web-based reading incl. MPR, MIP, volume rendering and image fusion. This solution is based on a solution of our partner Softneta.

Staying up to date with our certification is essential in the medical device field. We do our due diligence and update our own devices accordingly. When we partner with other vendors, we actively choose companies with the same approach to market registration.

Softneta not only received their CE certification according to the MDR, but also was cleared by FDA for diagnostic use including mammographic images (

This opens up the pathway for our North American sales team to approach clients interested in remote zero-footprint mammography reading. We celebrate with our partner this success in legal compliance.