EXINI Diagnostics AB

EXINI news

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.

Collaboration with Veterans Affairs in United States on the AI Research Program for Medical Image Analysis

On July 25, 2019, EXINI a fully owned subsidiary of Progenics Pharmaceuticals, entered into collaboration with the Veterans Affairs Greater Los Angeles Healthcare System (VAGLAHS), United States, on its AI research program. The collaborative program aims to apply machine learning to medical imaging modalities, enabling standardized, information-driven healthcare practices in prostate cancer. The project is the nation’s first collaborative effort to validate cutting-edge machine learning tools for improving treatment management of Veterans with prostate cancer.

EXINI PSMA-AI device highlighted at SNMMI 2019

June 24, at Anaheim, CA – EXINI team presented the performance of PSMA-AI device in an independent and prospectively defined study. The work was selected for an Oral presentation at SNMMI2019 and was picked for discussion in the highlight summary session. 

In a prospectively defined independent study, the data demonstrated that the AI-device assisted reads were better than manual only read in terms of speed, precision and diagnostic accuracy. The data is part of continual effort to enhance the clinical utility of imaging biomarkers with standardized and accurate assessment. 

Our focus remains on using technology to address clinically relevant questions for treatment management of Prostate Cancer. 

EXINI Agreement with FUJIFILM Toyama Chemical Co. in Japan

As of June 18, 2019, EXINI, a wholly owned subsidiary of Progenics Pharmaceuticals Inc. has entered into a licence and transfer agreement with FUJIFILM Toyama Chemical Co, Ltd. (FFTC) for the rights to Automated Bone Scan Index (aBSI) product in Japan for use under the name BONENAVI.

aBSI has become an integral component of prostate cancer practice patterns in Japan, and we are delighted to continue our relationship with FFTC, a leading Japanese pharmaceutical and diagnostic company, to offer this optimized and quick response technology solution to support physician treatment decisions for prostate cancer patients.