hema.to is FDA compliant

In record time ...

.. we've achieved FDA-compliance (as a class I device) less than four months after receiving our CE mark. This was made possible by the professionalism and dedication of our team, but in particular by our US regulatory partner QServe Group, and our contact Jennifer Hadfield (left in picture), and our EU regulatory partner Be-on-Quality. The picture shows Aleks and Jennifer registering our device; the following day the FDA sent us the good news.


Clinical study published

Clinical trial reveals hema.to is faster and better

We're incredibly proud to share that hema.to has been clinically validated in an international, four-center clinical trial! Blood cancer diagnoses weren't just twice as fast, they were made with 8% more sensitivity and 10% more specificity when made with the help of our beautiful, easy-to-use decision-support software. You can download the press release here.


Medical Valley first prize

hema.to won the first prize ...

... at the Medical Innovation Night in Nürnberg, where we pitched hema.to in front of an audience an an excellent jury consisting of Medical Valley EMN e. V., Siemens Healthineers, aescuvest, GWQ ServicePlus AG, IONOS andFraunhofer IIS. We'll be using our E20k prize money to explore partnerships with GWQ and Siemens Healthineers.


hema.to receives its CE mark

After months of hard work ...

... we are now compliant with the IVDD. We conform to ISO 13485 (quality management), ISO 14971 (risk management), ISO 62366 (usability), ISO 62304 (software life-cycle management) and IEC 82304 (health software).