EXINI
Our History
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.
EXINI Diagnostics AB, a wholly owned subsidiary of Lantheus Holdings, Inc., an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence (AI) solutions to Find, Fight and Follow serious medical conditions.
Quality Assurance
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.
EU
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). The Notified Body TÜV SÜD is responsible for the conformity assessments of EXINI certifications. EXINI Diagnostics’ commercially available products for clinical use; aPROMISE, aBSI and EXINI bone, are CE-marked according to the MDR 2017/745.
USA
EXINI has also implemented the FDA quality system regulation, 21 CFR Part 820 in our Quality Management System. PYLARIFY AI is commercially available in the US. aPROMISE received 510(k) clearance in July 2021 (K211655) and aPROMISE X received 510(k) clearance in February 2022 (K220590). aBSI is commercially available and was cleared in the United States in August 2019 (K191262).