EXINI receives FDA clearance for aBSI in United States
In August, EXINI received 510(k) clearance from the FDA to market aBSI for clinical use in the U.S. The clearance of a cloud based software as a medical device is an essential step towards the further development and clearance of the PSMA(PyL) AI product. In October, we were able to release aBSI 3.5.0 as the first FDA cleared aBSI version.
“The FDA clearance is a validation of our approach in using AI technology to solve clinically relevant problems in disease management of patients with prostate cancer” said Aseem Anand, Vice President and Site Manager of EXINI Diagnostics AB, Sweden.