EXINI Diagnostics AB was established in 1999 to commercialize AI methods for automated analysis of diagnostic images developed by a research group at Lund University. As a certified medical device manufacturer, EXINI has developed automated analysis platforms for cardiac, brain and bone scans. The company has always been innovative, developing web-based systems in the early 2000s. EXINIs most widely distributed platform is used to calculate the automated Bone Scan Index, which quantifies the bone tumor burden in patients with metastatic prostate cancer. This platform has been installed at about 1,000 hospitals worldwide. In 2015, EXINI was acquired by Progenics Pharmaceuticals Inc. for developing patient centric AI technologies for PSMA-targeted theranostic agents. In 2020, Progenics Pharmaceuticals, Inc. was acquired by Lantheus Holdings, Inc.
Quality assurance is at the center of EXINI Diagnostics’ core business. The foundation of the company is the medical tradition of evidence-based research. Being a part of the health care sector also demands that the company upholds a high standard of quality in its products and services.
EXINI Diagnostics has a certified Quality Management System in accordance with ISO 13485:2016 and certificate of compliance with European Medical Device Regulation 2017/745 (MDR) and European Council Directive MDD 93/42/EEC concerning medical devices. The Notified Body TÜV SÜD is responsible for the conformity assessments of EXINI certifications. EXINI Diagnostics’ product aPROMISE is CE-marked according to the MDR 2017/745 and the products aBSI and EXINI bone are CE marked according to the MDD 93/42/EEC. Both aBSI and EXINI bone are under transitioning for compliance with the MDR 2017/745.
EXINI has also implemented the FDA quality system regulation, 21 CFR Part 820 in our Quality Management System. aPROMISE received 510(k) clearance in July 2021 (K211655) and aBSI was cleared in the United States in August 2019 (K191262). Our legacy product EXINI, received a FDA 510(k) clearance in 2012 (K122205). Additionally our procedures follow all other applicable laws, regulations and guidelines in Europe, USA and other markets in which we are represented.