ScreenPoint Medical highlights Transpara regulatory clearances

Regulatory clearance is an important milestone for each medical device supplier, including providers of artificial intelligence solutions. Clearances require strict adherence to national and international standards and expectations such as FDA clearance in the United States, Conformité Européenne marking in the European Economic Area, and Health Canada licensing, among many others.

ScreenPoint Medical has attained regulatory clearance for its algorithms in 40 countries across the globe and is FDA-cleared (K241831 and K232096) and CE (0344) certified. As part of our CE marking, ScreenPoint Medical is proud to note that Transpara Detection can be used “as decision support, as an independent second reader, or as a tool to optimize workflow. If double reading is practiced, users may decide to use Transpara as a (partial) replacement of the second reader or as a third reader.”

From clearance to the clinic

Since earning this CE-mark approval several years ago, Transpara has moved far beyond accreditation, into proven clinical adoption and measurable impact across Europe.

Today, roughly 65% of Danish screening programs, 40% of Swedish regions, and one-third of Spain’s screening population are actively implementing Transpara Detection as a second reader or triage solution. Large-scale studies from Denmark, Norway, and Spain attest to its real-world impact.

The results observed in these national programs mirror those of Sweden's MASAI randomized controlled trial, the first and only  RCT ever conducted in this field, demonstrating that Transpara Detection improves cancer detection by 29% while reducing reading workload by 44%. A newly launched randomized controlled trial (PRISM) in the United States  will also use and study Transpara over the next few years.

From verification to value

Transpara is already shaping the future of screening. Cleared by regulatory bodies worldwide. Validated by 50+ peer-reviewed studies. Deployed on a national and global scale. Trusted by radiologists. Proven time and again to empower patients. 

As ScreenPoint Medical’s CEO Pieter Kroese recently wrote, “While other solutions in the market may require a qualifier - “more research is needed” - for Transpara, the results are clear: consistently and cumulatively, Transpara is proven as a new standard of care for your programme’s workflow and your population’s well-being.”

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