Healthplus.ai is proud to announce that it has achieved CE certification under the Medical Device Regulation for its innovative Software as a Medical Device (SaMD), PERISCOPE®. With this certificate, every hospital in the EU can now use PERISCOPE®  to predict infections after operations.

 

The innovative solution uses existing electronic patient records to early and accurately predict the risks of infections that can occur within 7 and 30 days after surgery per patient. An important milestone for patient care and safety: infections can occur in 1 in 5 patients. This doubles the recovery time and increases treatment costs by 35 million euros per hospital per year. In addition, infections are responsible for the majority of readmissions.

 

PERISCOPE® is unique in its kind: there is no comparable product worldwide. The certification therefore marks a special moment in the development of AI healthcare solutions; Particularly in the field of AI, in which only a small number of medical devices are MDR certified.

 

The MDR certification follows the successful completion of the REACT-EU project that the consortium of Healthplus.ai, PW Consulting and SAS has been working on over the past two and a half years. The aim of this project was to make Healthplus.ai’s artificial intelligence solution easy to implement and scalable and cost-effective in multiple hospitals, which has now been achieved. This allows all hospitals within the EU to easily implement PERISCOPE®.

 

Using insights from successful pilot programs in six leading hospitals in Europe and now the US, Healthplus.ai has developed a deep understanding of the complex requirements within the healthcare ecosystem. For example, PERISCOPE® recalibrates to each hospital and looks at the accuracy in 16 subgroups (such as gender, age) and is only used when an outcome meets qualitative benchmarks.

 

Healthplus.ai will first focus on Europe, while also pursuing FDA approval for the US market. This strategic expansion underscores Healthplus.ai’s commitment to improving surgical health outcomes worldwide. The organization wants to demonstrate the concrete impact of their solution on patient care, outcomes and finances and wants to set new standards in the sector of predictive medical software solutions.